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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05714384
• Other study ID #: 2238
• Status: Enrolling by invitation
• Start date: March 5, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Ministry of Health, Kuwait
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 126
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periapical Diseases
• Root Canal Infection

Intervention

Device:
• CeraSeal (Calcium Silicate-based Root Canal Sealer)
A calcium silicate-based root canal sealer will be used in cases requiring root canal retreatment.

Locations

Country	Name	City	State
Kuwait	Jaber Al-Ahmed Dental Center	Janub As Surrah	Hawalli Governate

Sponsors (1)

Lead Sponsor	Collaborator
Ministry of Health, Kuwait

Country where clinical trial is conducted

Kuwait, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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