Clinical Efficacy of AH Plus Bioceramic Sealer

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to assess the efficacy and outcome of sealer-based obturation (SBO) using a new calcium silicate sealer in comparison with warm vertical compaction (WVC) using a resin-based sealer, which is the current gold standard.

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.

Official Title
-----------------
Clinical Efficacy of AH Plus Bioceramic Sealer in Root Canal Treatment of Molar Teeth: A Randomized Controlled Trial

Conditions
-----------------
Root Canal Infection, Periapical Periodontitis, Periapical Diseases

Intervention / Treatment
-----------------
* Device: AH Plus Bioceramic Sealer
* Device: AH Plus Sealer (resin-based)


Participation Criteria
=================
Eligibility 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 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Permuted block randomization using a block size of 4 will be used to randomly select 212 participants (106 participants in each group). The Study Randomizer website (http://www.studyrandomizer.com) will be utilized to generate the randomization list and participants will be assigned to the selected treatment group accordingly.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBO with AH Plus Bioceramic Sealer<br>The teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer. | Device: AH Plus Bioceramic Sealer<br>* 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.<br>|
| Active Comparator: WVC with resin-based AH Plus Sealer<br>The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer. | Device: AH Plus Sealer (resin-based)<br>* 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.<br>|

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. | Change from baseline periapical lesion size at 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). | Change from baseline at 12 months |