[version 1; peer review: 1 approved]
No competing interests were disclosed.
Perforation can occur while performing root canal treatment. Biodentine has been made utilizing MTA (mineral trioxide aggregate) as a base, and claims to improve its properties in aspects such as physical property, durability, and handling, as well as its many other applications in restorative dentistry. The chemical components of SDF (silver diamine fluoride) have been suggested to have the following benefits: fluoride aids in remineralization and prevention, silver salts induce dentin sclerosis/calcification, and exhibit germicidal actions. It works by occluding dentinal tubules thus helping in preventing microleakage. This study aims to focus on the use of SDF on Biodentine and MTA as perforation repair material using a confocal microscope.
Mandibular molars will be selected for the study. The study will be divided into 4 groups: Group 1: Biodentine without application of 38% SDF; Group 2: Biodentine with the application of 38% SDF; Group 3: MTA Angelus without application of 38% SDF; and Group 4: MTA Angelus along with the application of 38% SDF. An artificial perforation 2 mm in diameter will be made directly in the middle of the pulpal floor. 38% silver diamine fluoride (FAMAGAIN) will be applied on the walls of the perforation according to the manufacturer’s instructions for the experimental groups (Groups 2 and 4). In the four groups, Biodentine will be applied in groups 1 and 2 and MTA will be applied in 3 and 4 (perforation repair material).
To evaluate the sealing capacity of perforation material in this study, we will use the average values of coronal dye leakage at the perforation site and Escobar’s criteria, which are used to assess the infiltration proportions.
Root canal therapy is a dental procedure that helps to alleviate pain caused by a tooth that is diseased or abscessed. The inflamed pulp is removed during the root canal procedure. Procedural errors are often seen during the treatment, which will have an overall impact on the outcome of the tooth. Furcal perforation is one of the most unpleasant and frequent accidents that can occur during endodontic treatment.
MTA (mineral trioxide aggregate) was introduced by Mahmoud Torabinejad in 1993, and was developed to treat perforations. The use of MTA can result in a complete seal between the root canal and the outer surface of the tooth.
Root perforation is thought to be an infinite pit in which repair material frequently escapes along the periodontal area. Some of the most important criteria for furcal perforation repair materials are their capacity to seal the surrounding tissues, their nontoxicity, and their ability to regulate the flow of material.
Since 1840, silver compounds have been administered in dentistry. Silver inhibits the growth of bacteria, and fluoride aids in remineralization and prevention.
Sometimes, perforation can occur due to large carious lesions, and attempts to remove caries can lead to bigger and wider perforation will lead to a poor prognosis of the teeth.
Biodentine and MTA have been used as root repair materials because of their ability to seal, being nontoxic and compatible with the surrounding tissue, and their ability to promote the regeneration of surrounding tissue. SDF can be used in addition to Biodentine and MTA as it is a widely used antibacterial compound. It has shown effectiveness in both hardening tooth structure and killing bacteria. Studies have been done to evaluate the microleakage of composites and GIC (glass inomer cement) in the application of SDF, and they have reported decreased microleakage after the application of SDF.
To assess the outcome and sealing ability of the application of Biodentine as a perforation repair material with the application of 38% SDF using dye penetration by a confocal laser microscope.
To assess the outcome and sealing ability of the application of Biodentine perforation repair material without the application of 38% SDF using dye penetration by a confocal laser microscope.
To assess the outcome and sealing ability of the application of MTA Angelus as a perforation repair material with the application of 38% SDF using dye penetration by a confocal laser microscope.
To assess the outcome and sealing ability of the application of MTA Angelus as a perforation repair material without the application of 38% SDF using dye penetration by a confocal laser microscope.
To compare the above parameters with each other.
Written informed consent was taken from patients who underwent extraction regarding the use of extracted teeth in this study.
Ethical approval was received from Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha (reference DMIHER (DU)/IEC/2023/581) on 06/02/2023.
This will be an in-vitro study with samples divided into four groups:
Group 1: Biodentine without application of 38% SDF.
Group 2: Biodentine with the application of 38% SDF.
Group 3: MTA Angelus without application of 38% SDF.
Group 4: MTA Angelus along with the application of 38% SDF.
The materials used in this study will be Biodentine™ (Septodont, Saint-Maur-des Fosses, France); MTA Angelus ® White (Angelus Lodrina, Parana Brazil); 38% silver diamine fluoride (Fagamin); Rhodamine B fluorescent dye; and a confocal laser microscope.
Freshly extracted permanent mandibular molars with intact tooth structure.
Teeth with caries and teeth with a fractured root will be excluded.
Mandibular permanent molars will be selected in this study. Calculus and soft tissue tags will be removed by ultrasonic scaling, and the teeth will be kept in 0.5% chloramine T for 7 days then in normal saline until the next step. After access cavity preparation of each molar, the crown will be sectioned up to the roof of the pulp chamber, and the apical one-third of the roots will be sectioned using straight fissure carbide bur.The root canal orifices in each selected tooth and the terminus of sectioned roots will be sealed using sticky wax. An artificial perforation of 2 mm in diameter will be made directly in the middle of the pulpal floor using a 2 mm width round bur in a high-speed handpiece with water coolant. The area will be then flushed with water and dried with compressed air. 38% silver diamine fluoride (FAMAGAIN) will be applied on the walls of the perforation according to the manufacturer’s instructions for the experimental group. Over which the perforation repair material, that is MTA and Biodentine, will be applied both in control and experimental groups.
The teeth will be randomly divided into four groups:
Group 1: Biodentine without application of 38% SDF.
Group 2: Biodentine with the application of 38% SDF.
Group 3: MTA Angelus without application of 38% SDF.
Group 4: MTA Angelus along with the application of 38% SDF.
After 24 hours, the teeth will be covered with two layers of clear, air-dry nail varnish leaving 1–2 mm around the perforation site exposed. Then, all teeth will be immersed in 100% humidity at 37°C for 24 hours, followed by immersion in 0.6% aqueous rhodamine B dye for 48 hours. Then each tooth will be sectioned longitudinally in a buccolingual direction and crossing the perforation site with a diamond disc (0.3mm thickness) and a water-cooled handpiece, and the maximum apical extent of dye leakage at the interfacial surface between tooth structure and repair material will be measured using a confocal microscope at 10× magnification. To evaluate the sealing capacity of perforation material in this study, we will use the average values of coronal dye leakage at the perforation site and Escobar’s criteria
0 – infiltration loss (dye penetration 0–<1.5 mm).
1 – simple infiltration (dye penetration 1.5–3 mm).
2 – medium infiltration (dye penetration > 3 mm).
The target sample size will be calculated using mean difference.
Primary variable: microleakage in millimetres Microleakage of MTA in mm = 1.24 ± 0.13 (as per reference article) Microleakage of MTA in mm = 0.88 ± 0.02 (as per reference article) Clinically relevant difference = 0.36 Pooled std.dev = 0.25 (estimated) As per reference articles. N1 = 2 *[(1.96+ 1.28)
2(0.25)
2] / (0.36)
2 = 10 Total samples required = 40
All the data will be analysed using SPSS version 27 software. Data for outcome variables will be tested for normality using the Kalmogorov-Smirnov test. The comparative analysis of the micro tensile bond strength will be evaluated on the measurement of Newton. ANOVA will be used to find the significant difference between the mean of the four groups. Tukey’s test will be used for comparative evaluation of measurement in between two groups pairwise. P-value ≤ 0.05 will be considered as significant at 5% level of significance and 95% confidence of interval.
Perforation is an unfortunate mishap that happens while performing root canal treatment. The size of the perforation, level, and position of the perforation, time of healing, and presence of periodontal or pulpal disorders are all factors that influence the result of perforated teeth.
It is expected that application of 38% of silver diamine fluoride on MTA Angelus and Biodentine may show better sealing ability than MTA Angelus and Biodentine alone.
The study may provide information about the new protocol which provides a better sealing ability to get the best outcome for the perforation repair by the clinician.
After obtaining the results of the data, we will publish them in a scientific journal.
The study began on 1 st August 2023, and is currently at the sample preparation stage.
No data are associated with this article.
I would like to thank my institute, my Guide, HOD and my colleagues.
Abstract: has been written in a structured manner giving the background and the method. Key words have been mentioned.
Introduction: Etiology of perforations, MTA have been explained well. One point which can be added is an enumeration of the various materials used to seal perforations, apart from MTA and Biodentine. You have to write the formulation available for SDF.
Rationale: Have been mentioned
Objectives: clearly written
Protocol: Groups have been defined. You have to mention the country of origin of Famagain.
Statistical tests have been mentioned and the sample size determination has been explained.
Estimation of the seal of the materials to the tooth structure will be measured with the CLSM.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
Reviewer Expertise:
Endodontic microbiology, sealing ability of perforation repair materials, outcomes of endodontic treatment
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.