Comparative analysis for variation of skeletal and dental parameters in bilateral cleft palate in central India population – A Nemoceph study

Shivani Rawat; Vikrant Jadhav; Priyanka Paul Madhu; Amit Reche; Aachal Lande

doi:10.12688/f1000research.135116.1

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Study Protocol

Comparative analysis for variation of skeletal and dental parameters in bilateral cleft palate in central India population – A Nemoceph study

[version 1; peer review: 2 approved with reservations, 1 not approved]

Shivani Rawat ¹, Vikrant Jadhav², Priyanka Paul Madhu¹, Amit Reche¹, Aachal Lande¹

Shivani Rawat ¹, Vikrant Jadhav², [...] Priyanka Paul Madhu¹, Amit Reche¹, Aachal Lande¹

PUBLISHED 21 Aug 2023

Author details Author details

¹ Public Health Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India
² Department of Orthodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India

Shivani Rawat
Roles: Conceptualization, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Vikrant Jadhav
Roles: Conceptualization, Methodology, Resources, Validation, Writing – Review & Editing

Priyanka Paul Madhu
Roles: Conceptualization, Formal Analysis, Project Administration, Writing – Review & Editing

Amit Reche
Roles: Conceptualization, Supervision, Writing – Review & Editing

Aachal Lande
Roles: Conceptualization, Data Curation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Introduction: An area of dentistry called orthodontics focuses on repositioning crooked teeth and regulating facial development. Orthodontists and oral surgeons use cephalometric analysis as a planning tool for their patient care. Conventional film-based radiography equipment has been replaced with direct digital devices, which have advantages such as reduced patient radiation exposure, immediate radiographic image generation, the removal of the need for darkrooms, and simple image sharing. The second-most typical craniofacial abnormality that results in birth abnormalities is cleft lip and palate. Such patients frequently do not receive cephalometric testing because of their hypoplastic growth and limited development. Research is needed to help plan a standard treatment regimen, perform orthognathic operations, and use a low-radiation analysis technique.
Objectives: To evaluate skeletal and dental parameters for cleft lip and palate using Down analysis, Steiner's analysis, and Tweed's analysis using Nemoceph.
Methods: Around 50 cases from cleft lip and palate and non-cleft lip and palate will be selected from the orthodontics department of Sharad Pawar Dental College and Hospital. Steiner's, Down's, and Tweed's analyses will be evaluated using Nemoceph. Further analysis will be conducted using the observational data from the readings. There will be millimetre-based measurements made. Comparative analysis will be done with one-way ANOVA and post hoc statistics and regression analysis will be done for association of demographic variables.
Expected outcomes: This study will use the nasion as a stable landmark to evaluate point A in cleft lip and palate patients, making it easier to perform normal cephalometric analysis. This will enable the evaluation of the probable position of point A for performing cephalometric analysis in orthodontics.

Keywords

Cleft Lip & Palate, Cephalometric analysis, Down’s analysis, Steiner’s analysis, Tweed’s analysis, Nemoceph, Orthognathic surgery, Point A

Corresponding author: Shivani Rawat

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Rawat S et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Rawat S, Jadhav V, Madhu PP et al. Comparative analysis for variation of skeletal and dental parameters in bilateral cleft palate in central India population – A Nemoceph study [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1009 (https://doi.org/10.12688/f1000research.135116.1) First published: 21 Aug 2023, 12:1009 (https://doi.org/10.12688/f1000research.135116.1) Latest published: 21 Aug 2023, 12:1009 (https://doi.org/10.12688/f1000research.135116.1)

Introduction

Orthodontics is a branch of dentistry that not only deals with correcting misaligned teeth but also modifying facial growth and is a guide to reconstructing the architecture of the face.¹

Orthodontists and oral surgeons can also use cephalometric analysis as a tool for arranging their patient’s care.

One of the primary procedures in every orthodontic facility is the acquisition, tracing, and interpretation of cephalometric head films or radiographs. Cephalometry is a tool that orthodontics utilizes to aid in diagnostics and comprehensive treatment planning. In comparison to conventional film-based equipment, these devices have several benefits, which involve less radiation exposure to the patient, immediate production of radiographic images, the removal of the need for darkrooms, associated costs and time for development, storage, and handling, and ease of image sharing with the appropriate professionals.²

The Steiner analysis and the Downs analysis are two of the more widely utilized methods of analysis in orthodontics.³

The second-most common type of craniofacial defect known to cause birth deformities is cleft lip and palate (CLP) which is known to be brought about by varying factors, including smoking, and alcohol consumption during pregnancy. Feeding issues, speech issues, hearing issues and recurrent ear infections can arise from such illnesses.⁴^,⁵

Maxillae abnormalities are among the abnormal characteristics present in people with craniofacial malformations such as CLP. This reduces the precision of the data because it is challenging to locate specific landmarks on cephalometric radiography. Finding the “Gonion,” “point A,” or points connected to the maxillary incisor pairs of landmarks can be particularly challenging.⁶^–⁸

Patients with CLP frequently do not undergo cephalometric analysis since it is challenging to quantify the landmarks due to their hypoplastic maxillae and constrained growth. It has been found that patients who inquire about the necessity of a cephalogram are unable to get such an analysis.⁹

Very few studies have used cephalometric analysis due to the limited availability of sample data, prospective data, difficult treatment protocols, lack of comprehension, and lack of system development for cleft patients. Therefore, research is essential because it will aid in developing a standard treatment plan, carrying out orthognathic procedures, and employing a low-radiation analysis method.

Aim

To assess the reliability of Down’s analysis, Steiner’s analysis, and Tweed’s analysis in bilateral CLP in a central Indian population using lateral cephalogram.

Objectives

1. To evaluate skeletal and dental parameters for CLP using Down’s analysis, Steiner’s analysis, and Tweed’s analysis using Nemoceph.
2. To compare skeletal and dental parameters for CLP using Down’s analysis, Steiner’s analysis, and Tweed’s analysis with non-CLCP patients using Nemoceph.

Methods

The study design is a simple cross-sectional study and analytical study. The patients for the study will be selected from randomized control trails. A complete clinical examination will be done followed by case history, impression taking, model analysis, and radiographs such as lateral cephalograms. We are able to categorise the malocclusion into classes I, II, and III based on Angle’s malocclusion.

This study will employ nasion as one of the few consistent landmarks to establish the value for point A. This will support cephalometric study in patients with cleft lip and palate. On the contrary, the following mentioned modifiers can influence the outcomes of the study which are: patients with vertical and horizontal development patterns, non-syndromic instances such as isolated cleft lips, and patients with Angle’s class II and III subdivision. Patients undergoing presurgical nasoalveolar moulding (PNAM) (a non-surgical method of reshaping the alveolus, lips, and nostrils before primary cleft lip and palate surgery), and patients using chin cup facemask and headgear therapy during mixed dentition period are potential confounders of the study.

Ethical considerations

1. The research proposal has been approved by the ‘Institutional Research Ethics Committee of Datta Meghe Institute of Higher Education and Research, Deemed University’ Ref No- DMIHER (DU)/IEC/2023/705 approved on 15/02/2023.
2. Informed written consent will be obtained from all the participants.

Setting and study design

The study will be carried out at Sharad Pawar DMIHER, Sawangi (M), Wardha, following approval from the ‘Institutional Research Ethics Committee of Datta Meghe Institute of Higher Education and Research, Deemed University’. Informed written consent will be obtained from all the participants.

The patients will be chosen using random sampling method from the Orthodontic Department’s Smile Train Outpatient Department (OPD). Around 50 patients will be invited to participate in the study based on the inclusion and exclusion criteria.

The cephalometric analysis and landmark recognition will be performed on a laptop using a mouse-controlled cursor. The landmarks will be notes and Down’s analysis, Steiner’s analysis, and Tweed’s analysis will be traced and measured by the same investigation to avoid interobserver errors. For examination, a proprietary programme called Nemoceph (version no. 8) will be employed. Open-access alternatives that can perform the equivalent function include Cephalopoint, Cephninja, and Oneceph. The photos will be saved in JPEG and PDF formats with a maximum resolution setting of 200 dpi.¹⁰

Further analysis will be conducted using the observational data from the readings. There will be millimeter-based measurements made. Once entered, these readings will appear on a Microsoft Excel page (version 2019 16.0.6742.2048).

The magnitude of competence and social support will be expressed in percentages along with a 95% confidence interval. Comparative analysis will be done with one-way ANOVA and post hoc statistics and regression analysis will be done for association of demographic variables.

Inclusion criteria

1. Data regarding the cases will be evaluated for the age group 10–18 years.
2. Patients with maxillary deficiency in class I and III skeletal patients.

Exclusion criteria

1. Orthodontic treatment used in CLP instances.
2. Syndromic cases.

Data sources/measurement

To conduct the study, 50 digital lateral cephalograms of prospective orthodontic patients who reported to the outpatient department (OPD) of the Department of Orthodontics were taken. The cases that have visited the departmental OPD and smile train unit will be chosen based on the criteria for inclusion.

Digital cephalograms were taken on Cephalostat machine (Planmeca Proline CC panoramic Xay, Planmeca OY Helsinki Finland). Kodak film size 8×10 inches (18×24 cms) and cassettes with in-built intensifying screen speed 400 were used.

Bias

To reduce measurement error and provide an unbiased assessment will be done by the same examiner every two weeks.

Study size

Using Fisher’s arctanh transformation

C (r) = \frac{1}{2} log e \frac{(1 + r)}{(1 - r)}

C (r) = \frac{1}{2} log e \frac{(1 + r)}{(1 - r)}

N = {(\frac{Z 1 - \frac{α}{2} + Z 1 - β}{\frac{1}{2} log e \frac{(1 + r)}{(1 - r)}})}^{2} + 3

ANS-PNSC3VSNUNGL

0.128 = \frac{1}{2} log \frac{[1 + 0.90]}{1 - 0.90} = 0.6393

Z α = 1.96

Z β = 0.84

N = [1.96 + \frac{0.84}{0.6393}] 2 + 3 = 22.17

N = 25 samples needed in the study

Statistical methods

The statistical methods employed in this study include the Student’s t-test and correlation analysis. These techniques will be used to analyze the data and uncover a pattern between cleft lip and palate patients and non-cleft lip and palate patients. The study’s approach is influenced by the research conducted by Philine H. Doberschutz.¹¹ The formula for analysis is referenced from Lachin (1981), as documented in Controlled Clinical Trials.¹² For the purpose of data analysis, the study will utilize SPSS version 27.0 (RRID: SCR_002865), a widely recognized software tool in the field of statistics. This software will aid in processing and interpreting the collected data effectively.

Dissemination

Due to the abnormal anatomy of the patients with bilateral cleft lip and palate it is difficult to locate anatomic landmarks to study skeletal and dental parameters, and hence with this study, we will be able to evaluate point A with the help of stable landmarks which will be evaluated from the nasion. We will be able to determine the likely position of point A for performing cephalometric analysis in orthodontics. Evaluation of point A in CLP patients is challenging due to growth deformity in the maxilla, making it difficult to perform the normal cephalometric analysis.

Discussion

Cephalometry plays a vital role in deciding the diagnosis for the patient.¹³

Due to restrictions in the utility of 2D cephalometry, the world is shifting to a digital mode of intervention. Digital cephalometry reduces intra and interobserver variations giving more accurate data for the study. CLP patients have an underdeveloped maxilla and due to this, we are not able to locate landmarks for determining the analysis.¹⁴ Ege Doğan et al. (2020), stated that the objective of his study’s was to assess the preciseness of cephalometric measurement data using lateral cephalometry in individuals with CLP present unilaterally.¹⁵ It is crucial to pay close attention to the marking of the anterior nasal spine, point A, nasion, sub nasal, and upper 1 points that are present in cleft regions. Reliability restrictions are essential in cephalometric studies of patients with CLP to guide doctors.¹⁶ Due to hypoplastic maxilla, we are unable to locate point A and the anterior nasal spine, and these points aid in assessing the growth pattern and malocclusion of the patients.¹⁷

Catharina A.M. Bongaarts et al. stated that the landmarks point A, anterior nasal spine, and posterior nasal spine can be difficult to identify in unilateral cleft lip and palate patients with embryonic germs in the anterior maxilla, but no more accurate anatomical points were identified in this investigation. Caution should be used when interpreting cephalometric tests in unilateral CLP patients that use anterior nasal spine, posterior nasal spine, and point A.¹⁸

Manual Yudovich et al. (2015) described the importance of the cephalometric study as that it can help to optimize future treatment protocols, which helps to achieve the greatest potential function and aesthetics to raise the patient’s quality of life.¹⁹

As a result, a study was developed to evaluate the dental and skeletal characteristics of people with and without clefts to relocate to point A.

Study status

Not started yet.

Data availability

No data are associated with this article.

References

1. Proffit WR, Fields HW Jr, Sarver DM: Contemporary orthodontics. Elsevier Health Sciences. 2006 Dec 8.
2. Paredes V, Gandia JL, Cibrián R: Digital diagnosis records in orthodontics. An overview. Med. Oral Patol. Oral Cir. Bucal. 2006 Jan 1; 11(1): E88–E93. PubMed Abstract
3. Oria A, Schellino E, Massaglia M, et al.: A comparative evaluation of Steiner’s and McNamara’s methods for determining the position of the bone bases. Minerva Stomatol. 1991 Jun 1; 40(6): 381–385. PubMed Abstract
4. Quintero JC, Trosien A, Hatcher D, et al.: Craniofacial imaging in orthodontics: Historical perspective, current status, and future developments. Angle Orthod. 1999; 69: 491–506. PubMed Abstract
5. Shrey S, Singam A: A Comparative Study of Atracurium and Cisatracurium in paediatric cleft Lip and Cleft palate surgeries. Res. J. Pharm. Technol. 2020; 13(2): 867–870. Publisher Full Text
6. Kragskov J, Bosch C, Gyldensted C, et al.: Comparison of the reliability of craniofacial anatomic landmarks based on cephalometric radiographs and three-dimensional CT scANS. Cleft Palate Craniofac. J. 1997 Mar; 34(2): 111–116. PubMed Abstract | Publisher Full Text
7. Neelapu BC, Kharbanda OP, Sardana V, et al.: Automatic localization of three-dimensional cephalometric landmarks on CBCT images by extracting symmetry features of the skull. Dentomaxillofac. Radiol. 2018 Jan; 47(2): 20170054. PubMed Abstract | Publisher Full Text | Free Full Text
8. Midtgard J, Bjork G, Linder-Aronson ST: Reproducibility of cephalometric landmarks and errors of measurements of cephalometric cranial distances. Angle Orthod. 1974 Jan; 44(1): 56–61. PubMed Abstract
9. Hagemann K, Vollmer D, Niegel T, et al.: Prospective study on the reproducibility of cephalometric landmarks on conventional and digital lateral headfilms. J. OrofacOrthop. 2000; 61: 91–99. Publisher Full Text
10. Kumar M, Kumari S, Chandna A, et al.: Comparative evaluation of CephNinja for Android and NemoCeph for computer for cephalometric analysis: a study to evaluate the diagnostic performance of CephNinja for cephalometric analysis. J. Int. Soc. Prev. Community Dent. 2020 May; 10(3): 286–291. PubMed Abstract | Publisher Full Text | Free Full Text
11. Doberschütz PH, Schwahn C, Krey KF: Cephalometric analyses for cleft patients: a statistical approach to compare the variables of Delaire’s craniofacial analysis to Bergen analysis. Clin. Oral Investig. 2022 Jan; 26(1): 353–364. PubMed Abstract | Publisher Full Text | Free Full Text
12. Lachin JM: Introduction to sample size determination and power analysis for clinical trials. Control. Clin. Trials. 1981 Jun 1; 2(2): 93–113. Publisher Full Text
13. Chen SK, Chen YJ, Yao CC, et al.: Enhanced speed and precision of measurement in a computer-assisted digital cephalometric analysis system. Angle Orthod. 2004 Aug 1; 74(4): 501–507. PubMed Abstract
14. Verulkar A, Kamble R, Srivastav S, et al.: Evaluation of the awareness of different orthodontic treatment appliances in patients undergoing orthodontic treatment of Maharashtra–A survey. J. Datta Meghe Inst. Med. Sci. Univ. 2020 Jul 1; 15(3): 347. Publisher Full Text
15. Doğan E, Çınarcık H, Doğan S, et al.: Is Cephalometric Analysis Reliable in Cases with Cleft Lip and Palate? Ege Üniversitesi Diş Hekimliği Fakültesi Dergisi. 2020; 41(1): 27–37.
16. Midtgård J, Björk G, Linder-Aronson ST: Reproducibility of cephalometric landmarks and errors of measurements of cephalometric cranial distances. Angle Orthod. 1974 Jan; 44(1): 56–61. PubMed Abstract
17. Björk A: The face in profile. SvenskTandlaekare- Tidskrift, Vol. 40; No. 5B, suppl. Berlingska, Boktrykeriet, Lund.1947.
18. Bongaarts CA, van’t Hof MA , Prahl-Andersen B, et al.: Identification of cephalometric landmarks in unilateral cleft lip and palate patients: are there alternatives for point A, ANS, and PNS? Cleft Palate Craniofac. J. 2008 Jan; 45(1): 81–86. PubMed Abstract | Publisher Full Text
19. Burak MY, Ponglertnapakorn A, Calderón EG: Analysis of the cephalometric skeletal and dental characteristics of adult patients with cleft lip and palate who received orthopedic, orthodontic and/or surgical treatment during their childhood and adolescence. Revista Mexicana de Ortodoncia. 2015; 3(1): 22–32. Publisher Full Text

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Version 1

VERSION 1 PUBLISHED 21 Aug 2023

Author details Author details

¹ Public Health Dentistry, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India
² Department of Orthodontics, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India

Shivani Rawat
Roles: Conceptualization, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing

Vikrant Jadhav
Roles: Conceptualization, Methodology, Resources, Validation, Writing – Review & Editing

Priyanka Paul Madhu
Roles: Conceptualization, Formal Analysis, Project Administration, Writing – Review & Editing

Amit Reche
Roles: Conceptualization, Supervision, Writing – Review & Editing

Aachal Lande
Roles: Conceptualization, Data Curation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 21 Aug 2023, 12:1009

https://doi.org/10.12688/f1000research.135116.1

Copyright

© 2023 Rawat S et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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how to cite this article

Rawat S, Jadhav V, Madhu PP et al. Comparative analysis for variation of skeletal and dental parameters in bilateral cleft palate in central India population – A Nemoceph study [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1009 (https://doi.org/10.12688/f1000research.135116.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

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Open Peer Review

Current Reviewer Status: ?

Key to Reviewer Statuses VIEW HIDE

ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

Version 1

VERSION 1

PUBLISHED 21 Aug 2023

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Reviewer Report 30 Sep 2024

Shreyasi Tiwari, Meenakshi Mission Hospital & Research Centre, Madurai, India

Approved with Reservations

https://doi.org/10.5256/f1000research.148219.r321968

STUDY TITLE: Are the study subjects bilateral cleft palate or bilateral cleft lip & palate patients?

ABSTRACT:

The first sentence in the abstract introduction can be better framed. Please refrain from using

STUDY TITLE: Are the study subjects bilateral cleft palate or bilateral cleft lip & palate patients?

ABSTRACT:

The first sentence in the abstract introduction can be better framed. Please refrain from using layman's terms in a scientific paper.
CLP is the MOST common congenital abnormality in the facial region.
Precisely because of secondary maxillary hypoplasia, cleft individuals are usually advised to undergo serial lateral cephalometry, as opposed to what’s been mentioned by the authors.
Please mention 'lateral cephalometric analysis' & 'Bilateral' CLP under objectives in the abstract.
It’s unclear from the abstract methods whether there will be 50 subjects each in the CLP & non-CLP groups, or only 25 subjects per group. Will only millimetre-based measurements be made or angular measurements in degrees too?
The science behind the reasoning under ‘expected outcomes’ of the abstract is quite obscure.

INTRODUCTION:

Tweed’s analysis has been missed out.
CLP is the most common craniofacial congenital deformity, not the second most common.
The etiology of cleft remains unclear, although the combination of genetic and environmental factors is indisputable.
The scientific basis for the claims made in the last two paragraphs of the introduction isn’t very clear. Individuals with CLP quite often are subjected serial radiography (especially in dedicated cleft centres) – cleft data is generally very well-documented in centres receiving funding for cleft orthodontic care.

METHODS:

It's not clear how 'randomized controlled trial' (RCT) is applicable in the research methodology of this protocol.
The claim that Nasion landmark will be employed for better interpretation of point A, thereby making this current study protocol helpful in cleft cephalometry is repeatedly mentioned to somehow highlight the usefulness of this study. However, the scientific reasoning behind this is unclear.
The second paragraph mentions ‘non-syndromic instances such as isolated cleft lips’ under study modifier, which makes the reader believe that the study subjects are only syndromic individuals. The last two sentences of the second paragraph regarding ‘modifiers’ & ‘confounders’ can be better phrased to convey the intended scientific meaning.
The selection criteria of the present protocol is very obscure. The cleft and non-cleft groups must be matched with respect to parameters such as age, sex, etc. For selection within the BCLP group, there must be congruence in relation to the clinical presentation of cleft prior to the primary repair surgery, operating Surgeon & technique, ages at which primary lip & palate repair surgeries were performed, no. of revision surgeries, information about alveolar bone grafting etc. Also, the specified age group in the inclusion criteria is too vast for any fruitful data analysis.
Reasoning behind using the said three cephalometric analyses has not been provided. It’s unclear if only millimetre-based measurements will be done or angular ones as well. Also, much stress has been laid on NemoCeph software more often than required (including in the study title).
The study investigators must preferably be two or more well-experienced Cleft Orthodontists.
The grammar in the methodology keeps changing from past to present to future tenses.
Despite the elaborate sample size calculation equations provided, it’s unclear how the figure of 25 subjects was arrived at.
The statistical analysis mentioned in the abstract and that under the study methodology are not in agreement. Intra-observer reliability has not been mentioned.

DISSEMINATION & DISCUSSION require complete revision.

It isn’t clearly justified by the authors on how this study will add to the currently available scientific literature.

The grammar used in the study protocol can be improved, in general.

The use of more relevant references is encouraged.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Cleft & Craniofacial Orthodontics

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report 25 Sep 2024

Marcela Scarpa, Plastic Surgery, Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil

Not Approved

https://doi.org/10.5256/f1000research.148219.r321965

1. In the received work, there are some conceptual errors:
- Cleft lip and palate are the most common congenital facial defects (present in 1:650 live births) and the second most prevalent congenital defect (only less common than ... Continue reading

1. In the received work, there are some conceptual errors:
- Cleft lip and palate are the most common congenital facial defects (present in 1:650 live births) and the second most prevalent congenital defect (only less common than clubfoot).
- Its primary causal condition is genetic, but it can also be influenced by environmental factors, epigenetics, and random causes.

- Two-dimensional cephalometry is widely studied and described in the literature; however, it is incomplete due to its inherent limitations and parallax errors.
         - Cleft lip and palate are very common, and there is no shortage of data.
         - Treatment protocols are well-documented and extensively studied (up to the present day) and registered in large multicentric studies such as Eurocleft, Americleft, and Scandcleft.
         - Patients with cleft lip and palate may undergo cephalometry; however, three-dimensional evaluation is currently well-documented in the literature.

2. Objective:
- The objective of the study is unclear:
         - Is it to validate the Nemoceph software?
         - To evaluate cephalometric changes in patients with bilateral cleft lip and palate? If this is the objective, craniofacial changes have already been well-documented in the literature.

3. Method:
- A single evaluator is not adequate for the analysis. Even with an assessment at two different time points, evaluation by only one person is inherently biased. I suggest at least two expert evaluators at two distinct times to minimize errors.
- If the objective is to validate the software, I suggest comparing the results with those of other recognized methods that can prove the effectiveness and accuracy of the Nemoceph analysis.

- Regarding the age of the patients:
- The range of 10-18 years is too broad, as mixed dentition can occur up to 12 years.
- This period can interfere with facial growth and compromise the analysis.

- If the objective is to validate the software, I would be happy to review the article again, provided the suggested changes are made.

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

References

1. Molina-Solana R, Yáñez-Vico RM, Iglesias-Linares A, Mendoza-Mendoza A, et al.: Current concepts on the effect of environmental factors on cleft lip and palate.Int J Oral Maxillofac Surg. 2013; 42 (2): 177-84 PubMed Abstract | Publisher Full Text
2. Holmes LB, Baldwin EJ, Smith CR, Habecker E, et al.: Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy.Neurology. 2008; 70 (22 Pt 2): 2152-8 PubMed Abstract | Publisher Full Text
3. Lin KJ, Mitchell AA, Yau WP, Louik C, et al.: Maternal exposure to amoxicillin and the risk of oral clefts.Epidemiology. 2012; 23 (5): 699-705 PubMed Abstract | Publisher Full Text
4. Parveen S, Husain A, Johns G, Mascarenhas R, et al.: Three-Dimensional Analysis of Craniofacial Structures of Individuals With Nonsyndromic Unilateral Complete Cleft Lip and Palate.J Craniofac Surg. 32 (1): e65-e69 PubMed Abstract | Publisher Full Text
5. Shaw WC, Brattström V, Mølsted K, Prahl-Andersen B, et al.: The Eurocleft study: intercenter study of treatment outcome in patients with complete cleft lip and palate. Part 5: discussion and conclusions.Cleft Palate Craniofac J. 2005; 42 (1): 93-8 PubMed Abstract | Publisher Full Text
6. Russell K, Long RE, Hathaway R, Daskalogiannakis J, et al.: The Americleft study: an inter-center study of treatment outcomes for patients with unilateral cleft lip and palate part 5. General discussion and conclusions.Cleft Palate Craniofac J. 2011; 48 (3): 265-70 PubMed Abstract | Publisher Full Text
7. Küseler A, Heliövaara A, Mølsted K, Marcusson A, et al.: Scandcleft trial of primary surgery for unilateral cleft lip and palate: Craniofacial cephalometrics at 8 years.Eur J Orthod. 2021; 43 (4): 374-380 PubMed Abstract | Publisher Full Text
8. Cleft Lip and Palate Treatment. 2018. Publisher Full Text
9. Carlson JC, Nidey NL, Butali A, Buxo CJ, et al.: Genome-wide interaction studies identify sex-specific risk alleles for nonsyndromic orofacial clefts.Genet Epidemiol. 2018; 42 (7): 664-672 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Maxillofacial, Cleft lip and palate, craniofacial

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report 22 Feb 2024

Mohammad Abdelhamid, Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology, Mansoura, Dakahlia, Egypt

Approved with Reservations

https://doi.org/10.5256/f1000research.148219.r248256

Dear authors,
Thanks for submitting this study protocol to F1000Research.
The study within hands is a cross-sectional analytical study that is proposed to assess the reliability of a software program; Nemoceph, in assessing the variation of skeletal and ... Continue reading

Dear authors,
Thanks for submitting this study protocol to F1000Research.
The study within hands is a cross-sectional analytical study that is proposed to assess the reliability of a software program; Nemoceph, in assessing the variation of skeletal and dental parameters in patients with bilateral cleft lip and palate, and correlating these results with measurements of patients without cleft lip and palate using digital cephalometric analysis.
The protocol is neat and valid, but it may need some modifications so that the exerted efforts could be shown clearer.

Title:
- I think the enrolled patients to be considered are cleft lip and palate patients and not just cleft palate patients.
- The term "patients" should be added within the title.
- In addition, I wonder about the expression " A Nemoceph study". Up to my knowledge NemoCeph is a software program and not a type of study.
- Therefore, I recommend that the title would be "Comparative analysis for variation of skeletal and dental parameters in bilateral cleft lip and palate patients in central India population: A cross-sectional analytical study using NemoCeph program".

Introduction:
- 5th text line: utilizes --> utilize.
- 10th text line: more --> most.
- 11th text line: the second most common : What is the first most common? If it's clubbed foot - as I think - then it's not a craniofacial anomaly. Thus, CLP is the first most common craniofacial anomaly and the second most common body anomaly among humans.

Objectives:
2- To compare skeletal and dental parameters for CLP using Down’s analysis, Steiner’s analysis, and Tweed’s analysis with non-CLCP patients using Nemoceph: You mean to compare with data published in the literature, or with data acquired from enrolled patients without CLP. (This was not declared within the manuscript !)
- CLCP: This abbreviation wasn't defined within the manuscript, I think you mean CLP instead.

Methods:
- The hypotheses, both null and alternative hypotheses, are missing. Please state.
- Grouping identification is missing as well. How would you name each group within your study?
- 2nd text line: trails --> trials.
- 4th text line: A reference is needed at the end of the paragraph.
- 11th text line: potential confounders of the study --> So, will they be excluded from the study? If yes, then please mention that in the exclusion criteria.

Setting and study design:
- 4th text line: using random sampling method --> Please define the method of randomization that will be used within your study.
- 8th text line: notes --> noted.
- 9th text line: investigation --> investigator.
- 9th, 10th, and 11th text line: I think you need to state the corporations that have the mentioned program rights.

Exclusion criteria:
- What if the enrolled patients have undergone alveolar cleft bone grafting (ABG)? Will they be excluded? As you know, ABG would affect the measurement parameters, especially when the included age that you stated in the inclusion criteria is referring to that when most CLP patients have undergone ABG (Secondary alveolar cleft bone grafting (SABG)).
- Also, What about unilateral CLP patients? Will they be excluded as well? If yes, please mention.

Data sources/measurements:
- 2nd text line: The cases that have visited ....etc. --> Referring to ‘patients’ as ‘cases’
throughout your manuscript is inappropriate. According to the AMA Manual of Style³, “the use of case is dehumanizing when referring to a specific person”.
Please rephrase ‘cases’ into ‘patients’ whenever mentioned. Here we are not talking about AMA as a referencing style, but rather as a writing style.

Bias:
- 1st text line: " ... and provide an unbiased assessment will be ..." --> " .... and provide an unbiased assessment, measurements will be ...". Please rephrase.
- 1st text line: " .... every 2 weeks." --> for how long? and, How many times?
- If the same examiner will do multiple measurements for the same sample, then I think you'll need assessment for the intraobserver reliability.

Study size:
- I think that the term "Sample size" is more appropriate than "Study size".
- ANS-PNSC3VSNUNGL: Please clarify this expression.
- N= 25 samples ... etc: --> Then, will you enroll 50 patients (as stated in the 'Setting and study design' section) or 25 patients (as stated here)?
- I'm a little bit confused about the input values within the used formula. Please declare.

Statistical methods:
- 5th text line: SPSS version 27.0 --> I think you need to state the corporation that have the program rights (IBM Inc,).

Discussion:
- 4th and 5th text lines: Ege Doğan et al. (2020), --> Doğan et al. (2020),.
- 7th text line: upper 1 --> Please declare!
- 8th text line: doctors --> Which doctors? Surgeons? Orthodontists? Or more broadly; cleft care providers?
- 11th text line: Catharina A.M. Bongaarts et al. --> Bongaarts et al. (Please add a reference for this citation and the year of the mentioned publication).
- 11th text line: " ... nasal spine can be ..." --> Please use the past tense. (i.e., " ... nasal spine could be ... " or "... nasal spine were ...").
- 15th text line: Manual Yudovich et al. --> By referring to the manuscript's bibliography, this citation should be cited as follows: Burak et al.

Again, endeavors of this manuscript authors are appreciated, and the above mentioned comments were highlighted from the reviewer's point of view for a better show of the already-shown efforts.

Best regards.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Thapliyal G: Peterson's Principles of Oral & Maxillofacial Surgery. Medical Journal Armed Forces India. 2006; 62 (1). Publisher Full Text
2. Dixon MJ, Marazita ML, Beaty TH, Murray JC: Cleft lip and palate: understanding genetic and environmental influences.Nat Rev Genet. 2011; 12 (3): 167-78 PubMed Abstract | Publisher Full Text
3. AMA Manual of Style Committee: AMA Manual of Style. 2020. Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Oral and maxillofacial surgery, Cleft lip and palate, Craniofacial abnormalities

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Mohammad Abdelhamid, Delta University for Science and Technology, Mansoura, Egypt
Marcela Scarpa, Faculdade de Medicina do ABC, Santo André, Brazil
Shreyasi Tiwari, Meenakshi Mission Hospital & Research Centre, Madurai, India

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6 Views

30 Sep 2024 | for Version 1

Shreyasi Tiwari, Meenakshi Mission Hospital & Research Centre, Madurai, India

6 Views Cite this report Responses(0)

Approved With Reservations

STUDY TITLE: Are the study subjects bilateral cleft palate or bilateral cleft lip & palate patients?

ABSTRACT:

The first sentence in the abstract introduction can be better framed. Please refrain from using layman's terms in a scientific paper.
CLP is the MOST common congenital abnormality in the facial region.
Precisely because of secondary maxillary hypoplasia, cleft individuals are usually advised to undergo serial lateral cephalometry, as opposed to what’s been mentioned by the authors.
Please mention 'lateral cephalometric analysis' & 'Bilateral' CLP under objectives in the abstract.
It’s unclear from the abstract methods whether there will be 50 subjects each in the CLP & non-CLP groups, or only 25 subjects per group. Will only millimetre-based measurements be made or angular measurements in degrees too?
The science behind the reasoning under ‘expected outcomes’ of the abstract is quite obscure.

INTRODUCTION:

Tweed’s analysis has been missed out.
CLP is the most common craniofacial congenital deformity, not the second most common.
The etiology of cleft remains unclear, although the combination of genetic and environmental factors is indisputable.
The scientific basis for the claims made in the last two paragraphs of the introduction isn’t very clear. Individuals with CLP quite often are subjected serial radiography (especially in dedicated cleft centres) – cleft data is generally very well-documented in centres receiving funding for cleft orthodontic care.

METHODS:

It's not clear how 'randomized controlled trial' (RCT) is applicable in the research methodology of this protocol.
The claim that Nasion landmark will be employed for better interpretation of point A, thereby making this current study protocol helpful in cleft cephalometry is repeatedly mentioned to somehow highlight the usefulness of this study. However, the scientific reasoning behind this is unclear.
The second paragraph mentions ‘non-syndromic instances such as isolated cleft lips’ under study modifier, which makes the reader believe that the study subjects are only syndromic individuals. The last two sentences of the second paragraph regarding ‘modifiers’ & ‘confounders’ can be better phrased to convey the intended scientific meaning.
The selection criteria of the present protocol is very obscure. The cleft and non-cleft groups must be matched with respect to parameters such as age, sex, etc. For selection within the BCLP group, there must be congruence in relation to the clinical presentation of cleft prior to the primary repair surgery, operating Surgeon & technique, ages at which primary lip & palate repair surgeries were performed, no. of revision surgeries, information about alveolar bone grafting etc. Also, the specified age group in the inclusion criteria is too vast for any fruitful data analysis.
Reasoning behind using the said three cephalometric analyses has not been provided. It’s unclear if only millimetre-based measurements will be done or angular ones as well. Also, much stress has been laid on NemoCeph software more often than required (including in the study title).
The study investigators must preferably be two or more well-experienced Cleft Orthodontists.
The grammar in the methodology keeps changing from past to present to future tenses.
Despite the elaborate sample size calculation equations provided, it’s unclear how the figure of 25 subjects was arrived at.
The statistical analysis mentioned in the abstract and that under the study methodology are not in agreement. Intra-observer reliability has not been mentioned.

DISSEMINATION & DISCUSSION require complete revision.

It isn’t clearly justified by the authors on how this study will add to the currently available scientific literature.

The grammar used in the study protocol can be improved, in general.

The use of more relevant references is encouraged.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Cleft & Craniofacial Orthodontics

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Reviewer Report

5 Views

25 Sep 2024 | for Version 1

Marcela Scarpa, Plastic Surgery, Faculdade de Medicina do ABC, Santo André, São Paulo, Brazil

5 Views Cite this report Responses(0)

Not Approved

1. In the received work, there are some conceptual errors:
- Cleft lip and palate are the most common congenital facial defects (present in 1:650 live births) and the second most prevalent congenital defect (only less common than clubfoot).
- Its primary causal condition is genetic, but it can also be influenced by environmental factors, epigenetics, and random causes.

- Two-dimensional cephalometry is widely studied and described in the literature; however, it is incomplete due to its inherent limitations and parallax errors.
         - Cleft lip and palate are very common, and there is no shortage of data.
         - Treatment protocols are well-documented and extensively studied (up to the present day) and registered in large multicentric studies such as Eurocleft, Americleft, and Scandcleft.
         - Patients with cleft lip and palate may undergo cephalometry; however, three-dimensional evaluation is currently well-documented in the literature.

2. Objective:
- The objective of the study is unclear:
         - Is it to validate the Nemoceph software?
         - To evaluate cephalometric changes in patients with bilateral cleft lip and palate? If this is the objective, craniofacial changes have already been well-documented in the literature.

3. Method:
- A single evaluator is not adequate for the analysis. Even with an assessment at two different time points, evaluation by only one person is inherently biased. I suggest at least two expert evaluators at two distinct times to minimize errors.
- If the objective is to validate the software, I suggest comparing the results with those of other recognized methods that can prove the effectiveness and accuracy of the Nemoceph analysis.

- Regarding the age of the patients:
- The range of 10-18 years is too broad, as mixed dentition can occur up to 12 years.
- This period can interfere with facial growth and compromise the analysis.

- If the objective is to validate the software, I would be happy to review the article again, provided the suggested changes are made.

Is the rationale for, and objectives of, the study clearly described?

No
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Partly

References

1. Molina-Solana R, Yáñez-Vico RM, Iglesias-Linares A, Mendoza-Mendoza A, et al.: Current concepts on the effect of environmental factors on cleft lip and palate.Int J Oral Maxillofac Surg. 2013; 42 (2): 177-84 PubMed Abstract | Publisher Full Text
2. Holmes LB, Baldwin EJ, Smith CR, Habecker E, et al.: Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy.Neurology. 2008; 70 (22 Pt 2): 2152-8 PubMed Abstract | Publisher Full Text
3. Lin KJ, Mitchell AA, Yau WP, Louik C, et al.: Maternal exposure to amoxicillin and the risk of oral clefts.Epidemiology. 2012; 23 (5): 699-705 PubMed Abstract | Publisher Full Text
4. Parveen S, Husain A, Johns G, Mascarenhas R, et al.: Three-Dimensional Analysis of Craniofacial Structures of Individuals With Nonsyndromic Unilateral Complete Cleft Lip and Palate.J Craniofac Surg. 32 (1): e65-e69 PubMed Abstract | Publisher Full Text
5. Shaw WC, Brattström V, Mølsted K, Prahl-Andersen B, et al.: The Eurocleft study: intercenter study of treatment outcome in patients with complete cleft lip and palate. Part 5: discussion and conclusions.Cleft Palate Craniofac J. 2005; 42 (1): 93-8 PubMed Abstract | Publisher Full Text
6. Russell K, Long RE, Hathaway R, Daskalogiannakis J, et al.: The Americleft study: an inter-center study of treatment outcomes for patients with unilateral cleft lip and palate part 5. General discussion and conclusions.Cleft Palate Craniofac J. 2011; 48 (3): 265-70 PubMed Abstract | Publisher Full Text
7. Küseler A, Heliövaara A, Mølsted K, Marcusson A, et al.: Scandcleft trial of primary surgery for unilateral cleft lip and palate: Craniofacial cephalometrics at 8 years.Eur J Orthod. 2021; 43 (4): 374-380 PubMed Abstract | Publisher Full Text
8. Cleft Lip and Palate Treatment. 2018. Publisher Full Text
9. Carlson JC, Nidey NL, Butali A, Buxo CJ, et al.: Genome-wide interaction studies identify sex-specific risk alleles for nonsyndromic orofacial clefts.Genet Epidemiol. 2018; 42 (7): 664-672 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Maxillofacial, Cleft lip and palate, craniofacial

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

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Reviewer Report

28 Views

22 Feb 2024 | for Version 1

Mohammad Abdelhamid, Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Delta University for Science and Technology, Mansoura, Dakahlia, Egypt

28 Views Cite this report Responses(0)

Approved With Reservations

Dear authors,
Thanks for submitting this study protocol to F1000Research.
The study within hands is a cross-sectional analytical study that is proposed to assess the reliability of a software program; Nemoceph, in assessing the variation of skeletal and dental parameters in patients with bilateral cleft lip and palate, and correlating these results with measurements of patients without cleft lip and palate using digital cephalometric analysis.
The protocol is neat and valid, but it may need some modifications so that the exerted efforts could be shown clearer.

Title:
- I think the enrolled patients to be considered are cleft lip and palate patients and not just cleft palate patients.
- The term "patients" should be added within the title.
- In addition, I wonder about the expression " A Nemoceph study". Up to my knowledge NemoCeph is a software program and not a type of study.
- Therefore, I recommend that the title would be "Comparative analysis for variation of skeletal and dental parameters in bilateral cleft lip and palate patients in central India population: A cross-sectional analytical study using NemoCeph program".

Introduction:
- 5th text line: utilizes --> utilize.
- 10th text line: more --> most.
- 11th text line: the second most common : What is the first most common? If it's clubbed foot - as I think - then it's not a craniofacial anomaly. Thus, CLP is the first most common craniofacial anomaly and the second most common body anomaly among humans.

Objectives:
2- To compare skeletal and dental parameters for CLP using Down’s analysis, Steiner’s analysis, and Tweed’s analysis with non-CLCP patients using Nemoceph: You mean to compare with data published in the literature, or with data acquired from enrolled patients without CLP. (This was not declared within the manuscript !)
- CLCP: This abbreviation wasn't defined within the manuscript, I think you mean CLP instead.

Methods:
- The hypotheses, both null and alternative hypotheses, are missing. Please state.
- Grouping identification is missing as well. How would you name each group within your study?
- 2nd text line: trails --> trials.
- 4th text line: A reference is needed at the end of the paragraph.
- 11th text line: potential confounders of the study --> So, will they be excluded from the study? If yes, then please mention that in the exclusion criteria.

Setting and study design:
- 4th text line: using random sampling method --> Please define the method of randomization that will be used within your study.
- 8th text line: notes --> noted.
- 9th text line: investigation --> investigator.
- 9th, 10th, and 11th text line: I think you need to state the corporations that have the mentioned program rights.

Exclusion criteria:
- What if the enrolled patients have undergone alveolar cleft bone grafting (ABG)? Will they be excluded? As you know, ABG would affect the measurement parameters, especially when the included age that you stated in the inclusion criteria is referring to that when most CLP patients have undergone ABG (Secondary alveolar cleft bone grafting (SABG)).
- Also, What about unilateral CLP patients? Will they be excluded as well? If yes, please mention.

Data sources/measurements:
- 2nd text line: The cases that have visited ....etc. --> Referring to ‘patients’ as ‘cases’
throughout your manuscript is inappropriate. According to the AMA Manual of Style³, “the use of case is dehumanizing when referring to a specific person”.
Please rephrase ‘cases’ into ‘patients’ whenever mentioned. Here we are not talking about AMA as a referencing style, but rather as a writing style.

Bias:
- 1st text line: " ... and provide an unbiased assessment will be ..." --> " .... and provide an unbiased assessment, measurements will be ...". Please rephrase.
- 1st text line: " .... every 2 weeks." --> for how long? and, How many times?
- If the same examiner will do multiple measurements for the same sample, then I think you'll need assessment for the intraobserver reliability.

Study size:
- I think that the term "Sample size" is more appropriate than "Study size".
- ANS-PNSC3VSNUNGL: Please clarify this expression.
- N= 25 samples ... etc: --> Then, will you enroll 50 patients (as stated in the 'Setting and study design' section) or 25 patients (as stated here)?
- I'm a little bit confused about the input values within the used formula. Please declare.

Statistical methods:
- 5th text line: SPSS version 27.0 --> I think you need to state the corporation that have the program rights (IBM Inc,).

Discussion:
- 4th and 5th text lines: Ege Doğan et al. (2020), --> Doğan et al. (2020),.
- 7th text line: upper 1 --> Please declare!
- 8th text line: doctors --> Which doctors? Surgeons? Orthodontists? Or more broadly; cleft care providers?
- 11th text line: Catharina A.M. Bongaarts et al. --> Bongaarts et al. (Please add a reference for this citation and the year of the mentioned publication).
- 11th text line: " ... nasal spine can be ..." --> Please use the past tense. (i.e., " ... nasal spine could be ... " or "... nasal spine were ...").
- 15th text line: Manual Yudovich et al. --> By referring to the manuscript's bibliography, this citation should be cited as follows: Burak et al.

Again, endeavors of this manuscript authors are appreciated, and the above mentioned comments were highlighted from the reviewer's point of view for a better show of the already-shown efforts.

Best regards.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Thapliyal G: Peterson's Principles of Oral & Maxillofacial Surgery. Medical Journal Armed Forces India. 2006; 62 (1). Publisher Full Text
2. Dixon MJ, Marazita ML, Beaty TH, Murray JC: Cleft lip and palate: understanding genetic and environmental influences.Nat Rev Genet. 2011; 12 (3): 167-78 PubMed Abstract | Publisher Full Text
3. AMA Manual of Style Committee: AMA Manual of Style. 2020. Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Oral and maxillofacial surgery, Cleft lip and palate, Craniofacial abnormalities

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

[1] 1. Proffit WR, Fields HW Jr, Sarver DM: Contemporary orthodontics. Elsevier Health Sciences. 2006 Dec 8.

[2] 2. Paredes V, Gandia JL, Cibrián R: Digital diagnosis records in orthodontics. An overview. Med. Oral Patol. Oral Cir. Bucal. 2006 Jan 1; 11(1): E88–E93. PubMed Abstract

[3] 3. Oria A, Schellino E, Massaglia M, et al.: A comparative evaluation of Steiner’s and McNamara’s methods for determining the position of the bone bases. Minerva Stomatol. 1991 Jun 1; 40(6): 381–385. PubMed Abstract

[4] 4. Quintero JC, Trosien A, Hatcher D, et al.: Craniofacial imaging in orthodontics: Historical perspective, current status, and future developments. Angle Orthod. 1999; 69: 491–506. PubMed Abstract

[5] 5. Shrey S, Singam A: A Comparative Study of Atracurium and Cisatracurium in paediatric cleft Lip and Cleft palate surgeries. Res. J. Pharm. Technol. 2020; 13(2): 867–870. Publisher Full Text

[6] 6. Kragskov J, Bosch C, Gyldensted C, et al.: Comparison of the reliability of craniofacial anatomic landmarks based on cephalometric radiographs and three-dimensional CT scANS. Cleft Palate Craniofac. J. 1997 Mar; 34(2): 111–116. PubMed Abstract | Publisher Full Text

[7] 7. Neelapu BC, Kharbanda OP, Sardana V, et al.: Automatic localization of three-dimensional cephalometric landmarks on CBCT images by extracting symmetry features of the skull. Dentomaxillofac. Radiol. 2018 Jan; 47(2): 20170054. PubMed Abstract | Publisher Full Text | Free Full Text

[8] 8. Midtgard J, Bjork G, Linder-Aronson ST: Reproducibility of cephalometric landmarks and errors of measurements of cephalometric cranial distances. Angle Orthod. 1974 Jan; 44(1): 56–61. PubMed Abstract

[9] 9. Hagemann K, Vollmer D, Niegel T, et al.: Prospective study on the reproducibility of cephalometric landmarks on conventional and digital lateral headfilms. J. OrofacOrthop. 2000; 61: 91–99. Publisher Full Text

[10] 10. Kumar M, Kumari S, Chandna A, et al.: Comparative evaluation of CephNinja for Android and NemoCeph for computer for cephalometric analysis: a study to evaluate the diagnostic performance of CephNinja for cephalometric analysis. J. Int. Soc. Prev. Community Dent. 2020 May; 10(3): 286–291. PubMed Abstract | Publisher Full Text | Free Full Text

[11] 11. Doberschütz PH, Schwahn C, Krey KF: Cephalometric analyses for cleft patients: a statistical approach to compare the variables of Delaire’s craniofacial analysis to Bergen analysis. Clin. Oral Investig. 2022 Jan; 26(1): 353–364. PubMed Abstract | Publisher Full Text | Free Full Text

[12] 12. Lachin JM: Introduction to sample size determination and power analysis for clinical trials. Control. Clin. Trials. 1981 Jun 1; 2(2): 93–113. Publisher Full Text

[13] 13. Chen SK, Chen YJ, Yao CC, et al.: Enhanced speed and precision of measurement in a computer-assisted digital cephalometric analysis system. Angle Orthod. 2004 Aug 1; 74(4): 501–507. PubMed Abstract

[14] 14. Verulkar A, Kamble R, Srivastav S, et al.: Evaluation of the awareness of different orthodontic treatment appliances in patients undergoing orthodontic treatment of Maharashtra–A survey. J. Datta Meghe Inst. Med. Sci. Univ. 2020 Jul 1; 15(3): 347. Publisher Full Text

[15] 15. Doğan E, Çınarcık H, Doğan S, et al.: Is Cephalometric Analysis Reliable in Cases with Cleft Lip and Palate? Ege Üniversitesi Diş Hekimliği Fakültesi Dergisi. 2020; 41(1): 27–37.

[16] 16. Midtgård J, Björk G, Linder-Aronson ST: Reproducibility of cephalometric landmarks and errors of measurements of cephalometric cranial distances. Angle Orthod. 1974 Jan; 44(1): 56–61. PubMed Abstract

[17] 17. Björk A: The face in profile. SvenskTandlaekare- Tidskrift, Vol. 40; No. 5B, suppl. Berlingska, Boktrykeriet, Lund.1947.

[18] 18. Bongaarts CA, van’t Hof MA , Prahl-Andersen B, et al.: Identification of cephalometric landmarks in unilateral cleft lip and palate patients: are there alternatives for point A, ANS, and PNS? Cleft Palate Craniofac. J. 2008 Jan; 45(1): 81–86. PubMed Abstract | Publisher Full Text

[19] 19. Burak MY, Ponglertnapakorn A, Calderón EG: Analysis of the cephalometric skeletal and dental characteristics of adult patients with cleft lip and palate who received orthopedic, orthodontic and/or surgical treatment during their childhood and adolescence. Revista Mexicana de Ortodoncia. 2015; 3(1): 22–32. Publisher Full Text

Comparative analysis for variation of skeletal and dental parameters in bilateral cleft palate in central India population – A Nemoceph study

Abstract

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Aim

Objectives

Methods

Ethical considerations

Setting and study design

Inclusion criteria

Exclusion criteria

Data sources/measurement

Bias

Study size

Statistical methods

Discussion

Study status

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References

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