Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects – A study protocol of randomized controlled trial

Ruchita Patil; Prasad V Dhadse

doi:10.12688/f1000research.133334.1

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Study Protocol

Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects – A study protocol of randomized controlled trial

[version 1; peer review: 1 not approved]

Ruchita Patil ¹, Prasad V Dhadse²

PUBLISHED 23 May 2023

Author details Author details

¹ PG, Department of Periodontics & Implantology, Datta Meghe institute of Higher education and Research, Sawangi, Wardha, Maharashtra, 442001, India
² HOD & Professor, Department of Periodontics & Implantology, Datta Meghe Institute of Higher Education & Research, Sawangi, Wardha, Maharashtra, 442001, India

Ruchita Patil
Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Project Administration, Resources, Writing – Original Draft Preparation

Prasad V Dhadse
Roles: Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

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

Abstract

BACKGROUND
Class II furcation is a significant clinical problem in dentistry. Its presence indicates advanced periodontitis. Different xenografts are available for the treatment of furcation involvement. Platelet concentrates that have been assimilated have a high concentration of growth factors, which has the added benefit of improving and accelerating healing.
This study aims to compare the evaluation of effectiveness of T-PRF with xenograft and collagen membrane with xenograft in class II furcation defects.
METHODS
A one-year timeframe is going to be utilized to carry out the planned protocol, which is a randomised clinical trial. According to the inclusion criteria, 26 systemically healthy patients with class II furcation defects in mandibular molars will be included in the study. In Group I, xenograft and T-PRF (test group) will be condensed and in Group II, xenograft and collagen membrane (control group) will be condensed after the complete debridement of the furcation defect. Plaque index (PI), papillary bleeding index (PBI), Periodontal pocket depth (PPD), relative attachment level (R-CAL) and relative gingival marginal level (R-GML) will be evaluated as the clinical parameters. Cone-beam computed tomography (CBCT) will be performed to measure furcation height (FH), furcation width (FW), and furcation depth (FD) defects of mandibular molars. Data from each group will be evaluated at the time of surgery (baseline), and three and six months after the surgery.
EXPECTED OUTCOMES
Using xenograft (FIX OSS) combined with T-PRF, the authors anticipate better outcomes for class II mandibular furcation defects (test group). Improved clinical and radiographic outcomes in terms of PPD, R-CAL, R-GML and FH, FW, FD, are anticipated.
CONCLUSIONS
Using xenograft in combination with the T-PRF procedure is anticipated to have a better combined effect on periodontal parameters, including hard tissues and soft tissue outcomes.
Registration: CTRI REF/2023/03/064367.

Keywords

Periodontitis, bovine derived-xenograft, regenerative treatment, GTR, collagene membrane, clinical trial.

Corresponding author: Ruchita Patil

Competing interests: No competing interests were disclosed.

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

Copyright: © 2023 Patil R and Dhadse PV. 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: Patil R and Dhadse PV. Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects – A study protocol of randomized controlled trial [version 1; peer review: 1 not approved]. F1000Research 2023, 12:535 (https://doi.org/10.12688/f1000research.133334.1) First published: 23 May 2023, 12:535 (https://doi.org/10.12688/f1000research.133334.1) Latest published: 23 May 2023, 12:535 (https://doi.org/10.12688/f1000research.133334.1)

Introduction

Periodontitis is “an infectious condition that affects the teeth's supporting tissues and is brought on by a particular bacterium or collection of bacterias, causing the alveolar bone and periodontal ligament to eventually degenerate and the production of greater probing depths”.¹ Periodontitis leads to tooth loss and due to its widespread occurrence, it has grown to be a major problem for public health.¹ Periodontitis is a condition that affects multi-rooted teeth more frequently and, if left untreated, damages the periodontal attachment and tooth-supporting tissues, eventually leading to intraosseous defects or furcation defects.²^,³ Class II furcation is of significant clinical concern because it leads to the loss of connective tissues as well as continuous resorption of alveolar bone.⁴

Furcation involvement is a complex anatomical structure that makes it challenging to complete debridement using traditional periodontal instruments.⁵^,⁶ For many years, mechanical debridement has been used in periodontal treatment to remove bacterial infections.⁷ Non-surgical mechanical debridement alone frequently causes disease progression in extensive furcation involvements.⁸ In the interest of preventing the progression of the disease, surgery enables access for periodontal regeneration, root debridement, osseous recontouring, odontoplasty, and detoxification while preserving periodontal attachment.⁹

A lost or damaged component is recreated or repaired by periodontal regeneration such that the structure and functionality of the tissue are fully restored. For the regeneration of the furcation, influencing factors include the use of bone grafts or bone replacement implants, as well as organic and synthetic barrier membranes, biological mediators, and growth factors.¹⁰

One of the most popular treatments is the use of varieties of bone grafts to fill the furcation defects and to restore the lost periodontal apparatus.¹¹ Among various bone grafts are autogenous bone, alloplasts, allografts and xenografts. In an autogenous graft, the patient's own bone is actually removed and used to induce osteogenesis, osteoinduction, and osteoconduction in order to make new bone. Allografts obtained from cadavers contain the osteoinductive and osteoconductive properties but not osteogenic ones. Xenografts and alloplasts often only have osteoconductive properties.¹²

High osteoconductive activity of deproteinized bovine bone material leads to extracellular bone matrix deposition and they are the most commonly utilised amongst natural bone fillers.¹³ The xenograft, which is made of bovine bone that has undergone acidic decalcification to remove its mineral content while maintaining its organic portion, contains some osteoinductive growth factors.¹⁴ FIX OSS is a new bovine derived xenograft which is a highly purified bone substitute material. The porous interconnecting architecture of FIX OSS mimics the natural bone structure and promotes faster bone regeneration and remodelling of the new bone.

Guided tissue regeneration (GTR) is a regeneration method that mainly entails repopulating the previously damaged root surface with selected progenitor cells while eliminating direct contact with the gingival epithelium and connective tissue.¹⁵ Fix Gide GTR is a bovine derived resorbable collagen membrane which has a unique bilayer structure that offers superior tissue compatibility and prevents the ingrowth of soft tissue into the augmented site.

In 2013, Tunali created titanium-prepared platelet rich fibrin (T-PRF) using biocompatible titanium tubes.¹⁶ It is a fibrin that resembles PRF but differs from PRF in that it has a denser fibrin network. Leukocytes and platelets are abundant. In order to extend intra-tissue fibrin resorption and progressively release growth factors, this denser fibrin structure is required.¹⁷ There is little recognition of the effectiveness T-PRF's profile.¹⁸

In order to address class II mandibular furcation defects, this study procedure was developed using T-PRF as a regeneration material along with xenograft. The aim of this randomized clinical trial protocol is the evaluation of the efficacy of xenograft and T-PRF in the management of class II mandibular furcation defects.

This clinical trial has been registered with Clinical Trial Registry of India on 04/03/2023, ref REF/2023/03/064367.

The study proposal is approved by the institutional ethics committee on 02/02/2023 with Ref No. DMIHER (DU)/IEC/2023/574. Patients’ informed consent will be taken prior to the procedure, including both written and verbal consent.

The present study is a randomised clinical trial and will be performed over a period of one years. Trial design will be an interventional type of trial. Allocation ratio will be 1:1.

The study participants’ allocation will be done by a dentist, according to the inclusion and exclusion criteria in the Outpatient Department (OPD) of Periodontics and Implantology, Sharad Pawar Dental College, Sawangi (Meghe), Wardha, Maharashtra, India after taking written informed consent.

Sample size calculation

Sample size was calculated using OpenEpi, version 3, open-source calculator, sum of square mean.

Formula using mean difference

n 1 = n 2 = 2 \frac{{(Z_{α} + Z_{β})}^{2} σ^{2}}{{(δ)}^{2}}

Z_{α} = 1.96

α = Type I error at 5 %

Z_{β} = 0.84 (1 - β) = Powerat 80 %

σ = std . dev

Primary variable (periodontal attachment level-vertical)

(Mandibular class II furcation, difference after 6 months) Mean ± SD. = 1.7 ± 1.5

As per reference articles - Andrej Djurkin et al., 2019.

N1 = 2^{*} [{(1.96 + 0.84)}^{2} {(1.7)}^{2}] / {(1.5)}^{2} = 13

Total samples required = 13 per group.

• Inclusion criteria

1) Buccal/lingual involvement with class II mandibular furcation defects.
2) Horizontal defect depth (HDD) not more than 6mm.
3) Vertical defect depth (VDD) of 3 mm.
4) The height of the proximal bone of the tooth involved in the study should be coronal to the level of the interradicular bones.
5) An adequate amount of keratinized tissue should be present (at least 2mm should be present from mucogingival junction to gingival margin).
6) The level of the affected tooth's gingival margin should be coronal to the fornix of the furcation.
7) Molars with radiographic indications of furcation defects (buccal, mesiobuccal or distobuccal and lingual).

• Exclusion criteria

1) Patients not adhering to continuance of periodontal maintenance programme.
2) A habit of smoking or consuming tobacco.
3) Presence of mobility in the selected tooth.
4) Allergic reactions to any materials involved.
5) Any earlier or previous periodontal regeneration procedures performed into chosen location or site.
6) Females who are pregnant or nursing.
7) Infectious disease in patients like hepatitis, HIV, or tuberculosis.
8) Patients having a history of systemic illness.

• Clinical parameters

Papillary bleeding index (PBI), plaque index (PI), periodontal pocket depth (PPD), relative attachment level (R-CAL), and relative gingival marginal level (R-GML) are the clinical parameters that will be reported. Furcation height (FH), furcation width (FW), and furcation depth (FD) will be measured radiographically. Prior to surgery (at baseline), three- and six-months following surgery, all clinical parameters will be collected. The study's radiographic bone fill will serve as the primary result, while gains in CAL and PPD will serve as the secondary results.

Measures

The full-mouth plaque index will be measured before the anaesthesia at the baseline as well as six months later.¹⁹ The papillary bleeding index will be used to assess gingival inflammation (PBI).²⁰

Probing measurements

A UNC-15 calibrated periodontal probe (University of North Carolina, Hu-Friedy) will be used to measure all clinical parameters while utilising surgical stents. At three locations on every furcation defect—line angle of distal and mesial as well as surface of midbuccal or midlingual— R-CAL and R-GML with the vertical probing pocket depth (V-PPD) will be recorded and the highest measurement will be considered.

The gingival margin will be measured from the inferior border of the acrylic stent's slots using the UNC-15 probe, and this measurement will be reported as the relative gingival marginal level (R-GML). The space between the pocket's base and the pocket and the inferior border of the stent will be measured using the UNC-15 probe to determine the relative clinical attachment level (R-CAL). From the pocket's base to its gingival margin, the vertical probing pocket depth will be determined (PPD). Using a curved, color-coded furcation probe with marks for 0-3, 3-6, and 6-9 mm, the furcation's horizontal probing depth (HPD) will be identified. Using the UNC-15 Probe, the keratinized gingiva’s (WKG) width will be estimated from the mucogingival junction's apical most point to the crest of the gingival edge. All clinical parameters will be documented at baseline, one and six months thereafter.

Radiographic measurements

Measurements of the following radiographic parameters will be made using cone-beam computed tomography (CBCT):

1) Furcation height (FH): this is the height between the base of the alveolar bone and the furcation fornix, which is the roof of the furcation.
2) Furcation width (FW): this term refers to the distance between the two roots that are the furthest distance from one another above the crest of the alveolar bone.
3) Furcation depth (FD): the distance between the inter-radicular bone and the crest of the alveolar bone.

• T-PRF membranes preparation

10 millilitres of blood will be drawn from the participants' antecubital veins by venepuncture in order to prepare T-PRF. The samples will be placed in the centrifuge and titanium test tubes in 30 seconds. For 10 minutes, it will be centrifuged at 2700 rpm. It will be possible to acquire the T-PRF clot after centrifugation. The fibrin clot that has formed in the centre of the tube and the remaining red blood cells will be eliminated. To obtain T-PRF membranes, the clot will be placed over PRF box and pushed.²¹

• Surgical procedure

The subjects will be instructed to gargle for one minute with a solution of 0.2% chlorhexidine gluconate before the treatment starts. The procedure will be conducted under asepsis. The area will be anaesthetized by nerve block and infiltration using 2% Xylocaine with a concentration of 1:80,000 epinephrine (Ligno-Ad local anaesthetic, Proxim Remedies, India). Among all local anaesthetic substances, lignocaine is regarded as the gold standard.¹⁹

• Flap design (incisions)

A crevicular incision will be made using a number 15 blade, on the buccal or lingual surfaces of the affected tooth. The incisions will be made interproximally to close the primary wound and fix the interdental papillae. The flap will cover the region proximal and distal to the affected tooth.

• Flap reflection

With the use of a periosteal elevator (24 G Hu-Friedy, USA), a full thickness mucoperiosteal flap shall be raised on the affected site to reveal the underlying defect margin. Extra caution will be required when removing granulation tissue to prevent flap perforation or papilla loss.

• Debridement and root surface management

Curettes (Osung), ultrasonic devices (Woodpecker HW-3H), and hand tools (GDC) will be used to debride the furcation dome on the root surface which is denuded. The root surfaces and furcation defects will be planed until a smooth, firm consistency is obtained.

At the site of the furcation, intraoperative measurements of the horizontal and vertical defect depth will be taken after physiologic saline solution irrigation and achieving hemostasis.

1) Horizontal defect depth (HDD): using UNC 15, the furcation area will be recorded horizontally at its deepest area, and a second probe will be positioned at the root surface's prominence to use as a reference the initial probe.
2) Vertical defect depth (VDD): using the furcation fornix as a constant point of reference, the depth of the furcation defect will be determined vertically. The sites will then assign by computer a random number to either the test or control group following the intraoperative measurements.

Procedure for test group

The full thickness flap will be raised and the area to be treated will achieve total isolation and hemostasis. Xenograft and T-PRF will be compressed in the furcation defect. After the membrane has been stabilised, suture and periodontal pack (COE Pack) will be given to the treated site.

• Procedure for control group

The site will achieve total isolation and hemostasis. Following the thorough debridement of the furcation defect, the xenograft and collagen membrane will be condensed. After stabilising the membrane, the flap will be stitched. On the site of treatment, a periodontal pack (COE Pack) will be placed.

• Post-operative care

Patients will be prescribed amoxicillin 500 mg, three times a day, along with ibuprofen 400 mg and paracetamol 325 mg after surgery for five days. The use of 0.2% chlorhexidine gluconate as a gargle is prescribed for patients for 4-6 weeks, two times a day. Patients will be instructed not to brush over the surgical area for 7 days after surgery. 7 days after the surgery, the periodontal pack and sutures will be removed and healing will be evaluated. With the use of rubber cups, polishing paste, and saline irrigation, the affected location should be protected. Subjects will be instructed to use a gentle toothbrush and cotton pellets to clean the operated site in an apico-coronal direction. Re-evaluation will be done one, three and six months post-operatively.

• Maintenance care

The participants will undergo another evaluation one, three, and six months after surgery. At each subsequent session, dental hygiene advice and a complete mouth oral prophylaxis using ultrasonic tools will be provided. During the first three months following the surgery, no clinical measurements will be taken.

• Statistical analysis (in OpenEpi, version 3)

All clinical measurements, including plaque index (PI), papillary bleeding index (PBI), pocket probing depth (PPD), relative clinical attachment level (R-CAL), and relative gingival marginal level (R-GML), will be calculated using the mean and standard deviation measurements. Data on the day of surgery, i.e., at baseline, to six months will be analysed using the Student’s paired t-test. To compare the two groups at baseline and six months later, we will use Student’s unpaired t-test. The Student's paired t-test will be used to compare the baseline and six-month PBI and PI. If the probability value (p) is less than 0.05, the difference will be deemed significant; if it is greater than 0.05, it will be deemed non-significant. To determine differences among each group, the Wilcoxon test or paired Student's t-test will be used. Student's t-test or Mann-Whitney will be used independently used to assess all hard and soft tissue factors.

Discussion

The effectiveness of a bovine-derived xenograft that with or without a collagen membrane for the treatment of Class II mandibular furcations on 32 furcation defects was examined by Andrej Djurkin et al. in a randomised clinical trial published in 2019. All clinical parameters were assessed at the six-month follow-up using a straight probe and a modified "Nabers probe". After six months, there was a favourable evolution in both the vertical and horizontal attachment levels. The measures taken did not differ significantly (*p >.05, unpaired t-test). Authors stated that a statistically significant difference was not found between the two treatments and that both were clinically effective.

In order to compare the effectiveness of xenograft alone or in conjunction with platelet rich fibrin (PRF) in the treatment of grade II furcation deformities, Ahmed Abdallah Khalil (2019) conducted a study in which they clinically and radiographically investigated a total of 40 grade II furcation defects in 20 split mouth patients. For open flap surgery, the chosen sites were split into two groups and treated with either xenograft (cerabone®) alone in Group I or xenograft (cerabone®) + PRF membrane in Group II. Clinical and radiographic evaluations were carried out at baseline (before to surgery) and six months following surgery. Plaque index (PI), gingival index (GI), horizontal clinical attachment level (HCAL), and vertical clinical attachment level (VCAL) were among the clinical criteria examined. The furcation depth (FD), furcation height (FH), and furcation width (FW) were measured at baseline and six months after surgery, using cone-beam computed tomography (CBCT). Both groups had a statistically significant decline in each clinical and radiographic assessment from the beginning to six months following surgery. After six months following surgery, Group II had significantly higher FD, FH, FW, and HCAL values than Group I. The authors claim that xenograft (cerabone®) plus PRF significantly improved on xenograft (cerabone®) alone in treating furcation grade II defects.

Expected outcome

In this protocol, we propose using the novel approach using T-PRF in grade II furcation defects. The combined effects of using T-PRF along with xenograft (FIX-OSS) will expect positive outcomes for better healing. This study plan is to accelerate the improvement of hard tissue outcomes and other periodontal parameters.

Dissemination

After the completion of the study the data will be publicly available. The raw data will be shared through a suitable repository (figshare).

Study status

The recruitment will begin September 2023.

Data availability

No data are associated with this protocol.

Reporting guidelines

SPIRIT checklist for ‘Comparative evaluation of the effectiveness of titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects – a randomized controlled trial’. https://doi.org/10.5281/zenodo.7779917.²²

References

1. Clinical and Cone-beam Computed Tomography Evaluation of Xenograft alone or in combination with Platelet Rich Fibrin in the Treatment of Grade II Mandibular Furcation Involvement. Oral Medicine, X-Ray, Oral Biology & Oral Pathology. April 2019; Volume 65(2): Page 1377–1387. Article 23. Publisher Full Text
2. Bevilacqua L, Fonzer A, et al.: outcome of different surgical approaches in the treatment of class II furcation defects in mandibular molars: A randomized clinical trial. the international journal of periodontics and restorative dentistry. 2020; 40(5): 693–701. PubMed Abstract | Publisher Full Text
3. Rani N, Kaushal S, Singh S: Evaluation of the relative efficacy of autologous platelet-rich fibrin membrane in combination with β-tricalcium phosphate (Septodont-resorbable tissue replacement)™ alloplast versus β-TCP alloplast alone in the treatment of grade II furcation defects. National journal of maxillofacial surgery. 2018; 9(2): 196.
4. Bjorn A, Hjort P: Bone loss of furcated mandibular molars. A longitudinal study. J. Clin. Periodontol. 1982; 9: 402–408. PubMed Abstract | Publisher Full Text
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6. Pisulkar SK, Agrawal R, Belkhode V, et al.: Perception of buccal corridor space on smile aesthetics among specialty dentist and layperson. J. Int. Soc. Prev. Community Dent . 2019 Sep; 9(5): 499–504. PubMed Abstract | Publisher Full Text
7. Bjorn A, Hjort P: Bone loss of furcated mandibular molars. A longitudinal study. J. Clin. Periodontol. 1982; 9: 402–408. PubMed Abstract | Publisher Full Text
8. Ghangurde AA, Ganji KK, Bhongade ML, et al.: Role of Chemically Modified Tetracyclines in the Management of Periodontal Diseases: A Review. Drug research. 2017 May; 67(05): 258–265. Publisher Full Text
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13. Nart J, Barallat L, Jimenez D, et al.: Radiographic and histological evaluation of deproteinized bovine bone mineral vs. deproteinized bovine bone mineral with 10% collagen in ridge preservation. A randomized controlled clinical trial. Clin. Oral Implants Res. 2017 Jul; 28(7): 840–848. View at: Publisher Site|Google Scholar. PubMed Abstract | Publisher Full Text
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15. Kannan AL, Bose BB, Muthu J, et al.: Efficacy of combination therapy using anorganic bovine bone graft with resorbable GTR membrane vs. open flap debridement alone in the management of grade II furcation defects in mandibular molars–A comparative study. Journal of International Society of Preventive & Community Dentistry. 2014 Nov; 4(Suppl 1): S38–S43. PubMed Abstract | Publisher Full Text
16. Oza R, Dhadse P: Evaluation of the effectiveness of Titanium-prepared Platelet rich Fibrin (T-PRF) and Demineralized Freeze-dried Bone Allograft (DFDBA) in socket preservation followed by implant placement using two stage approach. JPRI. 2021; 33(60B): 3763–3770. Publisher Full Text
17. Mitra DK, Potdar PN, Prithyani SS, et al.: Comparative study using autologous platelet-rich fibrin and titanium prepared platelet-rich fibrin in the treatment of infrabony defects: An in-vitro and In-vivo study. J. Indian. Soc. Periodontal. 2019; 23: 554–561. Publisher Full Text
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22. Dr Patil RT , Dr Dhadse PV : Comparative evaluation of the effectiveness of titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects –A Randomized Controlled Trial.2023. Publisher Full Text

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Author details Author details

¹ PG, Department of Periodontics & Implantology, Datta Meghe institute of Higher education and Research, Sawangi, Wardha, Maharashtra, 442001, India
² HOD & Professor, Department of Periodontics & Implantology, Datta Meghe Institute of Higher Education & Research, Sawangi, Wardha, Maharashtra, 442001, India

Ruchita Patil
Roles: Conceptualization, Data Curation, Funding Acquisition, Investigation, Project Administration, Resources, Writing – Original Draft Preparation

Prasad V Dhadse
Roles: Methodology, Supervision, 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.

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Published: 23 May 2023, 12:535

https://doi.org/10.12688/f1000research.133334.1

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© 2023 Patil R and Dhadse PV. 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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Patil R and Dhadse PV. Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects – A study protocol of randomized controlled trial [version 1; peer review: 1 not approved]. F1000Research 2023, 12:535 (https://doi.org/10.12688/f1000research.133334.1)

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Reviewer Report 15 Sep 2023

Lorenzo Bevilacqua, Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy

Not Approved

https://doi.org/10.5256/f1000research.146313.r203490

I was invited to review this manuscript. Title: Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects - A study protocol of ... Continue reading

I was invited to review this manuscript. Title: Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects - A study protocol of randomized controlled trial. Even though I applauded the work by the authors, however, I have concerns of this study protocol trial. This paper have high level of biases.

Introduction

Do not give a literature review here. There is a lack of studies on the influences of morphologic characteristics of the furcation defects. Also missing the results of previous clinical trials on the subject.
References are wrong (no matches and missing references). Whole text should be revised.
Please clearly outline your research question. Both aims and objectives must be convincingly elaborated.
A clear and indisputable null hypothesis would seem missing.

Methods

Please add the section. So it is not clear.
With all materials and methodologies, please use general names with your text, followed by (brand name; manufacturer, city, country) in parentheses. Check for uniform writing/formatting. Please provide complete information, and remember to ensure future readers to repeat your study.
What is the primary variable? In the section “Sample size calculation” is written Periodontal attachment level vertical along the text radiographic bone fill…However, there is not detail how evaluated these parameters.
To me, the control group is another test group should be without regenerative fill (e.g OFD).
There is not enough detail for Surgical procedure in order to replicate your study (coronal advancement? Type Sutures? Suspended sutures? Hand tools? Reconturing?…)
Periodontal pack is not used for regenerative therapy.
It is missing when the defect is radiographically revalued. One year? At 3 months or 6 is too short…overtreatment?
No test of normality of the distribution is provided. Why will the authors be used parametric data? For recall time points, which statistic analysis do you want use?

Discussion and Conclusions

Note to discuss the the limitations of the study more thoroughly. Are there any fatal shortcomings or drawbacks? Does your study provide opportunities to inform future research?
All in all, this section would not seem well elaborated, and is considered too short when reflecting on the topic bearing much wealth.

References

This section is in need of a thorough revision.

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

Partly
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

No

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Periodontology and Implantology

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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Lorenzo Bevilacqua, University of Trieste, Trieste, Italy

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15 Sep 2023 | for Version 1

Lorenzo Bevilacqua, Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Italy

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Not Approved

I was invited to review this manuscript. Title: Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects - A study protocol of randomized controlled trial. Even though I applauded the work by the authors, however, I have concerns of this study protocol trial. This paper have high level of biases.

Introduction

Do not give a literature review here. There is a lack of studies on the influences of morphologic characteristics of the furcation defects. Also missing the results of previous clinical trials on the subject.
References are wrong (no matches and missing references). Whole text should be revised.
Please clearly outline your research question. Both aims and objectives must be convincingly elaborated.
A clear and indisputable null hypothesis would seem missing.

Methods

Please add the section. So it is not clear.
With all materials and methodologies, please use general names with your text, followed by (brand name; manufacturer, city, country) in parentheses. Check for uniform writing/formatting. Please provide complete information, and remember to ensure future readers to repeat your study.
What is the primary variable? In the section “Sample size calculation” is written Periodontal attachment level vertical along the text radiographic bone fill…However, there is not detail how evaluated these parameters.
To me, the control group is another test group should be without regenerative fill (e.g OFD).
There is not enough detail for Surgical procedure in order to replicate your study (coronal advancement? Type Sutures? Suspended sutures? Hand tools? Reconturing?…)
Periodontal pack is not used for regenerative therapy.
It is missing when the defect is radiographically revalued. One year? At 3 months or 6 is too short…overtreatment?
No test of normality of the distribution is provided. Why will the authors be used parametric data? For recall time points, which statistic analysis do you want use?

Discussion and Conclusions

Note to discuss the the limitations of the study more thoroughly. Are there any fatal shortcomings or drawbacks? Does your study provide opportunities to inform future research?
All in all, this section would not seem well elaborated, and is considered too short when reflecting on the topic bearing much wealth.

References

This section is in need of a thorough revision.

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

Partly
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

No

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Periodontology and Implantology

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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[22] 22. Dr Patil RT , Dr Dhadse PV : Comparative evaluation of the effectiveness of titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects –A Randomized Controlled Trial.2023. Publisher Full Text

Comparative evaluation of the effectiveness of Titanium platelet rich fibrin (T-PRF) membrane and collagen membrane combined with xenograft in the treatment of mandibular class II furcation defects – A study protocol of randomized controlled trial

Abstract

Keywords

Introduction

Measures

Probing measurements

Radiographic measurements

Discussion

Expected outcome

Data availability

Reporting guidelines

References

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