- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05763420
Clinical Efficacy of AH Plus Bioceramic Sealer
Clinical Efficacy of AH Plus Bioceramic Sealer in Root Canal Treatment of Molar Teeth: A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Calcium silicate sealers are used in endodontics because of their biocompatibility, bioactive properties and fluid-tight seal that forms a chemical bond with root canal dentine. In vitro and retrospective studies have shown promising results. However, to date, there is a lack of prospective and well-controlled studies.
Aims and objectives:
- To compare the clinical outcome of SBO with WVC in primary root canal treatment.
- To compare the radiographic outcome of SBO with WVC in primary root canal treatment using periapical radiography (PA) and cone-beam computed tomography (CBCT).
Materials and Methods:
- Patients who are referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center and fulfil the inclusion/exclusion criteria of the study will be included.
- Informed consent will be obtained from all participants.
- Preoperative PA and CBCT scans will be taken.
- Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: SBO or Group B: WVC. The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canals are ready for obturation.
- All teeth will then be restored definitively.
- The participants will be recalled after 1 year for clinical and radiographic assessment using PA and CBCT scans.
- The participants will then be followed-up annually for up to 4 years.
- Statistical analysis will be performed.
- The design of the study will conform to the CONSORT statement.
- The study will be conducted in accordance with the Declaration of Helsinki, and ethical approval has been granted by the local health authority (ID: 2291).
Statistical and Analytical Plans:
Sample size estimation for the treatment outcome was performed using PASS 2019 computer software, utilizing information from previous studies on healing outcome after primary root canal treatment. For a two independent-samples t-test of proportions, at a power of 80% and a 5% significance level for a two-tailed test, detecting a 10% difference in healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size will be 212 teeth.
The outcome at a specific time-point (12 months) will be a primary response variable in analysis. Outcome will be the dependent variable in logistic regression models with different predictor variables: age, sex, periapical status, preoperative pain, patency, apical size, root filling quality and sealer used. Two-way interactions between factors will also be assessed.
Expected outcome (Null Hypothesis):
No significant difference will be found between the two groups in clinical and radiographic outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Hawalli Governate
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Janūb As Surrah, Hawalli Governate, Kuwait, 00000
- Jaber Al-Ahmed Dental Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
- Maxillary and mandibular first permanent molar teeth that require primary root canal treatment will be included
- 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 5mm probing
- Anterior, premolar and second/third molar teeth
- Teeth whose apices were over-enlarged at the time of pulp extirpation
- Teeth with broken instruments
- Teeth with blocked or non-negotiable canals
- Teeth with iatrogenic perforations
- Teeth with incomplete root formation
- Teeth with internal or external root resorption
- Teeth that have a poor restorative prognosis
- Teeth that require posts or extensive prosthetic rehabilitation
- Teeth with cracks
- Teeth that have been previously root-filled
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SBO with AH Plus Bioceramic Sealer
The teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer.
|
A bioactive, calcium silicate-based sealer will be used in combination with the core root canal filling material (gutta-percha).
It's premixed and is dispensed in the root canal via a fine disposable syringe.
|
Active Comparator: WVC with resin-based AH Plus Sealer
The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer.
|
A resin-based sealer will be used in combination with the core root canal material (gutta-percha).
It consists of two pastes that are mixed together in equal amounts prior to application.
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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)
Time Frame: Change from baseline periapical lesion size at 12 months
|
Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.
|
Change from baseline periapical lesion size at 12 months
|
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
Time Frame: Change from baseline at 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).
|
Change from baseline at 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2291
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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