Clinical Efficacy of AH Plus Bioceramic Sealer

Root Canal Infection Clinical Trial

Official title: Clinical Efficacy of AH Plus Bioceramic Sealer in Root Canal Treatment of Molar Teeth: A Randomized Controlled Trial

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

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:

1. To compare the clinical outcome of SBO with WVC in primary root canal treatment.

2. 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 for up to 4 years.

• 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 a power of 80% and a 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 pain, patency, apical size, root filling quality and sealer used. Two-way interactions between factors will also be assessed.

Expected outcome (Null Hypothesis):

No significant difference will be found between the two groups in clinical and radiographic outcomes. ;

Related Conditions & MeSH terms

• Periapical Diseases
• Periapical Periodontitis
• Periodontitis
• Root Canal Infection

• NCT number: NCT05763420
• Study type: Interventional
• Source: Ministry of Health, Kuwait
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 7, 2023
• Completion date: December 31, 2025