Sealer-Based Obturation With AH Plus Bioceramic Sealer vs. Warm Vertical Compaction With AH Plus

Overview

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.

Calcium silicate sealers are used in endodontics because of their biocompatibility, bioactivity, and their ability to form a hydroxyapatite-mediated interfacial bond with root canal dentine. Although in vitro and retrospective clinical studies have reported promising findings, there remains a lack of prospective, well-controlled trials evaluating their clinical and radiographic performance. Aims and Objectives: 1. To compare the clinical outcome of single-cone bioceramic obturation (SBO) with warm vertical compaction (WVC) in primary root canal treatment. 2. To compare the radiographic outcome of SBO and WVC using periapical (PA) radiographs and cone-beam computed tomography (CBCT). Materials and Methods: Patients referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center who fulfil the inclusion and exclusion criteria will be invited to participate. Written informed consent will be obtained from all participants. Preoperative PA radiographs and CBCT scans will be taken. After completion of root canal instrumentation, participants will be randomly allocated to either Group A: SBO or Group B: WVC. Participants will be blinded to the obturation technique. Allocation will remain concealed until canals are ready for obturation, at which time the treating clinician will be informed of the assigned method. All teeth will receive definitive restorations following obturation. Participants will be recalled at 12-24 months for clinical and radiographic evaluation using PA radiographs and CBCT, and will subsequently be followed annually for up to 5 years. The study will conform to the CONSORT statement and will be conducted in accordance with the Declaration of Helsinki. Ethical approval has been granted by the local health authority (ID: 2291). Statistical and Analytical Plan: The sample size was determined for a non-inferiority comparison of the primary success proportion between the treatment group (AH Plus Bioceramic Sealer) and the reference group. Assuming a reference-group success proportion of 92%, a non-inferiority margin of 13 percentage points (δ₀ = -0.13), and no true difference between groups under the alternative hypothesis (δ₁ = 0), a one-sided, two-sample Z-test with unpooled variance at a significance level of 0.05 required 54 evaluable participants per group (108 in total) to achieve 80% power. To account for an anticipated attrition rate of 30%, the enrollment target was inflated to 78 participants per group (156 in total), applying the formula N' = N / (1 - 0.30). All calculations were performed using PASS (NCSS, LLC, Kaysville, UT, USA). Healing at 12-24 months will serve as the dependent variable in logistic regression models. Predictor variables will include age, sex, preoperative status, presence of apical periodontitis, preoperative pain, patency, apical preparation size, root filling quality, and sealer type. Two-way interactions will be assessed. Analyses will follow the intention-to-treat principle. Null Hypothesis: H₀: There is no difference between SBO and WVC in clinical or radiographic healing outcomes at 12-24 months.

Conditions

Interventions

Eligibility

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Outcomes