Calcium Silicate Sealer-based Obturation in Root Canal Retreatment

NCT05714384 | Enrolling By Invitation

• 1 other identifier: 2238
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Root Canal Infection; Periapical Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

CeraSeal (Calcium Silicate-based Root Canal Sealer) DEVICE

A calcium silicate-based root canal sealer will be used in cases requiring root canal retreatment.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who present with symptomatic teeth and require root canal retreatment will be assessed based on inclusion and exclusion criteria.

You may qualify if:

• Participants must be 18-65 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

You may not qualify if:

• 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 5mm 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

Sponsors & Collaborators

• Ministry of Health, Kuwait: lead
• Kuwait Institute for Medical Specialization: collaborator

Study Sites (1)

Jaber Al-Ahmed Dental Center

Janūb as Surrah, Hawalli Governate, 00000, Kuwait

Location

MeSH Terms

Conditions

Periapical Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Specialist in Endodontics

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 6, 2023
• Study Start: March 5, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)