Outcome of Calcium Silicate Sealer-based Obturation in Root Canal Retreatment
Study Details
Study Description
Brief Summary
This study will evaluate the outcome of calcium silicate sealer-based obturations in root canal retreatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Specialty Dental Centre. 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 assessed.
Using the G-Power Version 3.1 program for conducting "Goodness of fit" chi-square test, it was determined for an estimated effect size of 0.30 and an alpha 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 115 teeth.
Study Design
Outcome Measures
Primary Outcome Measures
- Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index) [Comparison of periapical lesion size at baseline and 12 months]
Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.
- Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms [Comparison at baseline and 12 months]
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).
Eligibility Criteria
Criteria
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
-
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
-
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 non-negotiable canals
-
Teeth with broken instruments
-
Teeth with perforations
-
Teeth requiring posts
-
Teeth with cracks
-
Teeth with internal or external root resorption
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jaber Al-Ahmed Dental Specialty Centre | Janūb As Surrah | Hawalli Governate | Kuwait | 00000 |
Sponsors and Collaborators
- Ministry of Health, Kuwait
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2238