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Study Protocol

Comparative evaluation of periapical healing in response to calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph

[version 1; peer review: 2 approved with reservations, 1 not approved]
PUBLISHED 12 Sep 2023
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: Success of root canal treatment depends upon 3-D seal obtained after obturation without any presence of post-operative symptoms. The focus of this investigation is on ability of a sealer to form 3D seal and to reduce periapical lesion. The study aims to evaluate periapical healing of teeth treated with calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph. The objectives of this study will be to evaluate periapical healing ability of root canal treated teeth with Sealapex, Nanoseal-S and Bio-ceramic sealers over the time period of 3, 6 and 9 months; and to compare the periapical healing ability of a root canal treated tooth. 
Methods:  A total of 60 subjects having periapical radiolucencies will be divided into 3 groups of 20 subjects each; Group I- Calcium hydroxide based, Group II- Polydimethyl siloxane based and Group III- Calcium Silicate based sealers. Root canal procedure will be done. Patients will be recalled after 3, 6, 9 months for the evaluation of periapical healing and PAI score check-up using intraoral periapical radiograph. 
Expected results: It is expected that among the material used in the study Bio-Ceramic and Nanoseal-S sealer may give better results as compared to Sealapex used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability.
Conclusion: Comparison amongst the three sealers would provide us with the information about the best material which offers better periapical healing to get the best outcome of the root canal treatment by clinician.

Keywords

Periapical healing, Calcium hydroxide, Polydimethyl siloxane, Calcium Silicate based endodontic sealers.

Introduction

The ability to effectively obturate the prepared root canal space is one of the cornerstones to successful root canal therapy. Sealer and Gutta-percha can be used to effectively obturate the canal space.1 According to “Ingle and Bakland”, 60 percent of endodontic failures are caused by improper root canal obturation. Obturation’s main goal is to accomplish 3D hermetic sealing of the pulp chamber in order to form a fluid-tight seal and inhibit the invasion of the germs and toxins into the periapical tissues. Because of the complexity of the root canal system, a variety of procedures and sealers have been developed to ensure a perfect seal. The root canal sealer’s job is to create a link between the root dentine and core material, successfully preventing leaking.2

Several sealers contain antibacterial or therapeutic substances like calcium hydroxide or corticosteroids, despite the fact that current endodontics prioritises sealing and biocompatibility characteristics of the materials. An endodontic sealer must strike a precise balance between cytotoxicity and antibacterial characteristics.3

Through the apical foramina and lateral canals, sealants placed in root canals can potentially inhibit the repair of periodontal tissue.4 Localized inflammation caused on by root canal obturation materials may lead to postoperative pain. It has been linked to a variety of treatment factors, including WL evaluation using an apex-locator hooked up to each of the file, the number of appointments, equipment selection, and selection of the root canal sealer.5 The severity of inflammatory reactions is determined by various elements, the most important of which is the sealer’s composition. Bio-ceramics are metal oxides or ceramic materials that have improved antibacterial and antifungal activity, improved sealing and also they are biocompatible, are used in dentistry and medicine.6 “NanoSeal-S” is a root canal sealer; polydimethyl siloxane-based that is cold flowable and contains nano silver in chemical form. It has great sealing properties as well as good radio-opacity. Silver is used as a preservative in chemical form. This study compares and evaluates the periapical healing response to calcium hydroxide, polydimethyl siloxane, and calcium silicate based endodontic sealers using radiographs.7

Protocol

The study will be conducted in “Sharad Pawar Dental College, in Department of Conservative Dentistry and Endodontics.” The outpatient department will pick a total of 60 people requiring endodontic treatment with Periapical radiolucency of teeth ranging from 0.5 mm – 8 mm. Patient will be informed priorly about the procedure to be done and written consent will be taken. Detailed case history will be recorded to properly evaluate the symptoms of irreversible pulpitis and the teeth with periapical radiolucency. Sixty participants who met the inclusion criteria were asked to choose a paper chit from one of three sealer groups: group I consisted of participants who chose the sealer based on calcium hydroxide, group II consisted of participants who chose the sealer based on polydimethylsiloxane, and group III consisted of participants who chose the sealer based on calcium silicate, as shown in Table 1. In this way, random sampling of the participants was done by chit picking.

Table 1. Distribution of samples by randomization of 60 samples into three groups based on the use of material.

GroupsMaterialSample
Group ICalcium hydroxide basedN = 20
Group IIPolydimethyl siloxane basedN = 20
Group IIICalcium silicate basedN = 20

Study design: Cross-sectional

Sample size calculation: 60

Sample Size formula:

n=3x2+P.1P.N/C2N1+x2p.1P

Where’s

X2 is the chi square value at 5%. level of Significance for I degrees of freedom = 3.84

P = 50%. proportion = 0.50

N = No. of patients 64

C = Confidence interval of one choice = 5% = 0.05

n=3.84×0.50×0.50×64/0.052×63+384×0.50×0.50=54:97

n = 55 patients needed in the Study

Statistical Method: Pearson’s Correlation Coefficient

Software Used: SPSS 27-0 V, Graph Pad Prism 7.0v.

Formula Reference: Prashanth D.7

For the ease of calculation and statistics sample size confirmed to 60 consisting of 20 subjects in each group.

Distribution of samples (Table 1)

Inclusion criteria:

  • Patients requiring endodontic treatment

  • Periapical radiolucency of teeth ranging from (0.5 mm – 8 mm)

Exclusion criteria:

  • Patients who are medically/systemically compromised (with systemic diseases, immunosuppressive disease or patients on medications)

  • Teeth wherein, there is inability to reach the full working length.

Materials

  • 1. Sealapex, Root canal Sealer: Compositions: Calcium hydroxide, barium sulfate, zinc oxide, titanium dioxide and zinc stearate. Manufacturer: SybronEndo, Glendora, CA, USA

  • 2. Nanoseal-S: Composition: Polydimethyl siloxane, Nano Silver powder, Silicone Oil, Platinum Catalyst, Zirconium Dioxide, Paraffin Liquid. Manufacturer: PrevestDenpro, USA

  • 3. Meta CeraSeal Calcium Silicate-based Bio-ceramic Root Canal Sealer: Composition: Calcium silicates, Zirconium oxide, calcium hydroxide, calcium phosphate, filler, and thickening agents. Manufacturer: Met biomed

Treatment protocol

The entire procedure will be performed under rubber dam isolation. Excavation of caries, and access-opening will be done using a round bur. Access will be refined with safe end bur. Pulp will be extirpated with suitable barbed broch. Working length will be established with apex locater and confirmed using IOPA. A glide path will be created using Path finder files. The “ProTaper Gold system” will be utilized to reshape the root canals. An “X-Smart endodontic motor” will operate every rotary file. To prevent over-instrumentation, the apex locator will evaluate the working length after each step. After each instrument, “2 mL 2% sodium hypochlorite (NaOCl)” will be used to irrigate the canals. Depending on the size of the apical foramen, the master file will range in size from F1-F5. Ending irrigation will be done using ultrasonic activation for a time period of 30 seconds with each solution “i.e., 2.0 mL NaOCl, 2.0 mL 17% EDTA, and 2.0 mL NaOCl per canal”. Canals will be dried using appropriate absorbent points till the canal is dry. Master cone fit will be checked clinically and radiographically. Sealer application will be performed using lentulo spiral and obturation will be done utilizing the appropriate GP point. Permanent restoration will be done with composite. Patient will be recalled after 3, 6, 9 months for the evaluation of periapical healing and PAI score check-up using Intraoral periapical radiograph.

Statistical analysis

The collected data will be compiled for additional statistical evaluation. Both descriptive and analytical statistical techniques will be used to analyse the data. The mean difference between measurements taken at intervals of three months, six months, and nine months will be examined for statistical significance. Statistical analysis of the collected data will be done using Statistical Package of Social Sciences V27-0 and Graph Pad Prism V7.0.

Ethical considerations

An ethical letter was issued from the Datta Meghe Institute of Higher Education and Research’s ethical committee for carrying out the study. IEC No.: DMIMS (DU)/IEC/2022/769.

Expected results

It is expected that among the material used in the study Bio-Ceramic and Nanoseal-S sealer may give better results as compared to Sealapex used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability.

Dissemination

In this comparative study, the results expected are the superiority of one sealer over the other and hence, we could make better choice amongst the different sealers available in the market to produce successful outcome.

Study status

Conceptualization and piloting of study.

Discussion

Comparison among the endodontic sealers to evaluate its efficacy and clinical results have been performed by many authors. An author conducted the study where 3 sealers were used and evaluated. The materials investigated that included Proco-Sol, an epoxy resin, AH26, and Klorperka N0, a “resin-guttapercha-chloroform sealer,” which is based on zinc oxide and eugenol. Periapical lesions’ healing was observed for three years. Despite the fact that there were no statistically significant differences between the groups, the response to Kloroperka N0 seemed to be considerably lower than the responses to the other two groups.8

Another researcher evaluated the clinical and radiological results of three sealers, two of which contain calcium hydroxide. At the time of root filling, 204 teeth were assigned to one of three groups: PS group gutta-percha filled teeth and Procosol sealer; CR group, gutta-percha filled teeth and sealer CRCS; and SA group, gutta-percha filled teeth and Sealapex sealer. Overall, the treatment result were equivalent to, but slightly worse than, those previously reported from patients examined at the University of Oslo’s Dental School. The total effect of the sealer on the treatment outcome was found to be minor. Although root fillings with Ca (OH)2 may promote faster healing of the apical periodontitis or surgical damage, the subsequent results 3 to 4 years were comparable for zinc oxide-eugenol–based sealers with or without Ca (OH).9,10

In the other study, Colombo M et al. conducted a study on 810 roots to evaluate performance of endodontic sealers 810 roots were used to examine and evaluate the experimental clinical performance of endodontic sealers: Kloroperka N-0®, AH 26®, and ProcoSol®. Lateral condensation of gutta-percha and sealer by undergraduate students were done using a uniform technique. Prior to filling, the sealer was chosen at random. The patients were seen for a clinical and radiographic control assessment every year for four years, with the radiographs graded using the periapical index (PAI) grading system. Roots filled with or ProcoSol® or AH 26® had a better periapical state than roots filled with Kloroperka®. After one year, the change was considerable and lasted for the whole four-year observation period. The periapical index was found to be a good discriminatory tool for assessing treatment results in endodontics, outcome of endodontic treatment depends on the choice of sealer.11,12

George Taccio de Miranda’s investigation Canderio et al. investigated the physicochemical properties of Endosequence BC Sealer, a bio-ceramic root canal sealer.13 The results were compared to AH Plus cement in terms of radiopacity, pH, calcium ion release (Ca2+), and flow. ISO 6876/2001 criteria were used to assess radiopacity and flow. Metallic rings with a 10 mm diameter and a 1 mm in thickness were filled with cements for the investigation. The radiopacity was calculated using the radiographic density (mm Al). A flow-test was carried out using cement in 0.05 mL quantity on a glassslab. A weight of 120 grams was laid over cement with care. A computerised calliper was used to measure the greatest and smallest diameters of the discs created. With a spectrophotometer and a pH metre, the release of Ca2+ and pH were determined during a period of 3, 24, 72, 168, and 240 hours, respectively.14 The bio-ceramic endodontic cement has much lower radiopacity (3.84 mm Al) than AH Plus, according to their findings (6.90 mm Al). During the experimental periods, the pH and Calcium ions release of Endosequence BC Sealer was higher than those of AH Plus (P.05). AH Plus and BC Sealer had flow of 21.17 mm and 26.96 mm respectively, according to the flow test (P.05). According to ISO 6876/2001 recommendations, Endosequence BC Sealer demonstrated radiopacity and flow. The other physicochemical parameters investigated showed that a root canal sealer had favourable values.15

In our study we will be comparing the three endodontic sealers; it is expected that among the material used in the study Bio-Ceramic and Nanoseal-S sealer may give better results as compared to Sealapex used in routine practice due to its ability of anti-microbial properties, optimal biocompatibility and excellent sealing ability.

The study can provide us with the information about the best material which provide better periapical healing to get the best outcome of the root canal treatment by clinician. Further studies can be carried out using CBCT to get more accurate results over conventional intraoral periapical radiograph. Impossibility of controlling all variables such as varied healing time of patients may interfere with the results of the study.

Comparison amongst the three sealers would provide us with the information about the best material which offers better periapical healing to get the best outcome of the root canal treatment by clinician.

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Umre U, Sedani S, Nikhade P et al. Comparative evaluation of periapical healing in response to calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1139 (https://doi.org/10.12688/f1000research.133392.1)
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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Key to Reviewer Statuses VIEW
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 12 Sep 2023
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Reviewer Report 06 Jun 2024
Wei Fan, Wuhan University, Wuhan, China 
Approved with Reservations
VIEWS 3
This study aimed to compare the periapical healing response to different endodontic sealers, namely calcium hydroxide, polydimethyl siloxane, and calcium silicate-based sealers. I believe this article can be improved in the following aspects:
  1. Standardization
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Fan W. Reviewer Report For: Comparative evaluation of periapical healing in response to calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1139 (https://doi.org/10.5256/f1000research.146378.r276984)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
2
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Reviewer Report 03 Jun 2024
Mohamed Nagy, Ain Shams University, Cairo, Egypt 
Approved with Reservations
VIEWS 2
The article is a protocol for a clinical study comparing three endodontic sealers: Sealapex, Nanoseal-S, and Meta CeraSeal.  Authors will evaluate periapical healing using Periapical index scores after 3, 6, and 9 months.
The clinical relevance of the study ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Nagy M. Reviewer Report For: Comparative evaluation of periapical healing in response to calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1139 (https://doi.org/10.5256/f1000research.146378.r266144)
NOTE: 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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7
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Reviewer Report 14 Mar 2024
Olcay Özdemir, Karabük University, Karabük, Turkey 
Not Approved
VIEWS 7
Dear Editor /Authors, I have carefully evaluated the submitted manuscript, entitled: Comparative evaluation of periapical healing in response to calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph.
I have listed my comments below, appreciating ... Continue reading
CITE
CITE
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Özdemir O. Reviewer Report For: Comparative evaluation of periapical healing in response to calcium hydroxide, polydimethyl siloxane and calcium silicate based endodontic sealers using radiograph [version 1; peer review: 2 approved with reservations, 1 not approved]. F1000Research 2023, 12:1139 (https://doi.org/10.5256/f1000research.146378.r246901)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
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Comment
Alongside their report, reviewers assign a status to the article:
Approved - the 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 approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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