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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Periapical Diseases; Root Canal Infection
• Intervention / Treatment: Device: CeraSeal (Calcium Silicate-based Root Canal Sealer)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

Study Locations

• Kuwait
  • Hawalli Governate
    • Janūb As Surrah, Hawalli Governate, Kuwait, 00000
      • Jaber Al-Ahmed Dental Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients who present with persistent periapical disease and require root canal retreatment will be assessed based on inclusion and exclusion criteria.

Description

Inclusion Criteria:

• Participants must be 21-65 years of age at the time of recruitment
• Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
• Participants must not have known allergies to any materials used in the study
• Participants must agree to participate in the study by signing a consent form
• Participants must have good oral hygiene
• All types of permanent teeth that require root canal retreatment are included (incisors, canines, premolars & molars)
• The teeth must be restorable and have fully formed roots with no advanced periodontal disease

Exclusion Criteria:

• ASA classification of III or more
• Pregnant or breastfeeding women
• Patients who are unable to give consent
• Patients who have advanced periodontal disease or teeth with more than 4mm probing
• Teeth with incomplete root formation
• Teeth that have a poor restorative prognosis
• Teeth presenting with signs of a vertical root fracture
• Teeth with blocked or non-negotiable canals
• Teeth with broken instruments
• Teeth with iatrogenic perforations
• Teeth requiring posts or extensive prosthetic rehabilitation
• Teeth with cracks
• Teeth with internal or external root resorption
• Teeth with uncontrollable exudate

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)	Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.	Comparison of periapical lesion size at baseline and 12 months
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms	The examiner will label the teeth as having a normal clinical outcome (absence of pain, swelling and other symptoms, no sinus tract, no loss of function) or showing signs and symptoms clinical outcome (the tooth is associated with signs and/or symptoms of infection).	Comparison at baseline and 12 months

Collaborators and Investigators

• Sponsor: Ministry of Health, Kuwait

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 2238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No