Outcome of Calcium Silicate Sealer-based Obturation in Root Canal Retreatment

Root Canal Infection Clinical Trial

Official title: Outcome of Sealer-based Obturation Using a Calcium Silicate Sealer in Root Canal Retreatment: A CBCT-based Prospective Cohort Study

Status Enrolling by invitation

Clinical Trial Summary

This study will evaluate the outcome of calcium silicate sealer-based obturations in root canal retreatment.

Clinical Trial Description

There are a number of studies that have shown promising results with the use of calcium silicate sealer-based obturations in primary root canal treatments. However, to date, there is a lack of studies that evaluate the effectiveness of their use in secondary root canal treatments which are cases that typically present with more persistent infections. The aim of the proposed study is to assess the outcome of sealer-based obturations using a calcium silicate sealer in root canal retreatments and to identify potential predictor variables.

Questions:

• What is the success rate of calcium silicate sealer-based obturations in root canal retreatment?

• How does it compare to previous studies using conventional techniques?

• What are the potential prognostic factors for success and failure?

This will be a prospective cohort study conducted at Jaber Al-Ahmed Dental Center. Informed/written consent will be obtained from all patients. Root canal retreatments will be done by a specialist in endodontics using a calcium silicate-based sealer (CeraSeal, Meta Biomed) according to the best evidence-based standards. All of these treatments will be recorded into a database and be followed up by at least 12 months.

The clinical and radiographic records of each patient will be reviewed, and eligibility for the study was assessed based on inclusion and exclusion criteria. All data will be anonymized and extracted for analyses without a reference to participants.

The outcome at a specific time-point (12 months) will be a primary response variable of the analyses. Outcome will be the dependent variable in logistic regression models with different predictor variables: age, sex, tooth type, periapical status, preoperative pain, preoperative root filling quality, sinus tracts, presence of exudate during treatment, patency, apical size, sealer extrusion and weeks of medication. Separate simple logistic regressions will be performed for each predictor with the primary outcome. A sequential logistic regression model will then be used to assess outcome as a function of both independent measures. Two-way interactions between factors will also be assessed.

The G-Power Version 3.1 computer program was used to conduct a chi-square goodness of fit test. It was determined for a medium effect size of 0.30 and an alpha level of 0.05, 88 teeth will be required to achieve a power of 80%. Adjusting for a dropout rate of 30%, the required sample size will be 126 teeth. ;

Related Conditions & MeSH terms

• Periapical Diseases
• Root Canal Infection

• NCT number: NCT05714384
• Study type: Observational
• Source: Ministry of Health, Kuwait
• Status: Enrolling by invitation
• Start date: March 5, 2023
• Completion date: December 31, 2025