Calcium silicate sealers are used in endodontics because of their biocompatibility, bioactive properties and fluid-tight seal that forms a chemical bond with root canal dentine. In vitro and retrospective studies have shown promising results. However, to date, there is a lack of prospective and well-controlled studies.~Aims and objectives:~To compare the clinical outcome of SBO with WVC in primary root canal treatment.~To compare the radiographic outcome of SBO with WVC in primary root canal treatment using periapical radiography (PA) and cone-beam computed tomography (CBCT).~Materials and Methods:~Patients who are referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center and fulfil the inclusion/exclusion criteria of the study will be included.~Informed consent will be obtained from all participants.~Preoperative PA and CBCT scans will be taken.~Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: SBO or Group B: WVC. The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canals are ready for obturation.~All teeth will then be restored definitively.~The participants will be recalled after 1 year for clinical and radiographic assessment using PA and CBCT scans.~The participants will then be followed-up annually.~Statistical analysis will be performed.~The design of the study will conform to the CONSORT statement.~The study will be conducted in accordance with the Declaration of Helsinki, and ethical approval has been granted by the local health authority (ID: 2291).~Statistical and Analytical Plans:~Sample size estimation for the treatment outcome was performed using PASS 2019 computer software, utilizing information from previous studies on healing outcome after primary root canal treatment. For a two independent-samples t-test of proportions, at power of 80% and 5% significance level for a two-tailed test, detecting a 10% difference in healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size will be 212 teeth.~The outcome at a specific time-point (12 months) will be a primary response variable in analysis. Outcome will be the dependent variable in logistic regression models with different predictor variables: age, sex, periapical status, preoperative and postoperative pain, patency, apical size, root filling quality and sealer used. Two-way interactions between factors will also assessed.~Expected outcome (Null Hypothesis):~No significant difference will be found between the two groups in clinical and radiographic outcomes.
The goal of this clinical trial is to assess the efficacy and outcome of sealer-based obturation (SBO) using a new calcium silicate sealer in comparison with warm vertical compaction (WVC) using a resin-based sealer, which is the current gold standard.