Outcome of SBO With Calcium Silicate Sealer vs WVC With Resin Based Sealer

Study Overview
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Brief Summary
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A single blinded randomized controlled trial. 212 subjects (teeth), 106 in each of the 2 groups will be recruited from the patients referred to Kuwait Board of Endodontics for primary root canal treatment. The aim is to compare the outcome of sealer-based obturation (SBO) with calcium silicate sealer versus warm vertical compaction (WVC) and resin based sealer. Preoperative PA radiograph and CBCT will be taken. A 1 year follow up period will be arranged and another PA radiograph and CBCT will be taken. The preoperative, postoperative and review clinical and radiographic data will be analyzed

Detailed Description
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Aims and Objectives To compare the clinical outcome of the SBO with WVC in non-surgical root canal treatment. To compare the radiographic outcome of the SBO with WVC in non-surgical root canal treatment using periapical radiographs and CBCT scans. To assess the difference in postoperative pain between the 2 groups. To assess the difference in the time required to complete the obturation between the 2 groups. Materials and Methods Patients who are referred to the Kuwait Board of Endodontics for non-surgical root canal treatment and fulfil the inclusion/exclusion criteria of the study will be included Pre-operative periapical radiograph, CBCT scan and 11-point Numerical Rating Scale (NRS) will be taken. Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: obturation using SCCS or Group B: obturation using 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 canal/canals are ready for obturation. All teeth will then be restored definitively. The participants will be contacted via telephone 1, 3 and 7 days post-treatment to report their NRS pain score. The participants will be recalled after 1 year for clinical and radiographic assessment using periapical radiograph and CBCT scan. 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. 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 initial endodontic therapy. For a two independent-samples t-test of proportions, at power of 80% and 5% significance level for two-tailed test, detecting a 10% difference of healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size was 212 teeth. The slightly high 30% dropout rate is anticipated because most of the patients we treat are non-Kuwaiti nationals and their presence in the country after 1 year is not guaranteed.

Official Title
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The Outcome of Non-surgical Root Canal Treatment Using the Sealer-based With Calcium Silicate Sealer vs. Warm Vertical Compaction With AH+ Sealer. A Randomized Controlled Clinical Trial

Conditions
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Root Canal Obturation, Root Canal Filling, Sealer-based Obturation, Randomized Clinical Trial, Postoperative Pain, Resin Based Sealer, Warm Vertical Compaction

Intervention / Treatment
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* Device: TotalFill Bioceramic Sealer
* Device: AH+ Sealer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 are included (incisors, canines, premolars & molars) The teeth must be restorable and have fully formed roots with no advanced periodontal disease In the event that a patient has more than 1 tooth eligible for the study, only one tooth on the left and/or right side of the mouth will be selected at random. A maximum of 2 teeth per participant can be included in the study Exclusion Criteria: ASA classification of III or more Pregnant women Advanced periodontal disease or teeth with more than 5mm probing Teeth with incomplete root formation or root resorption Teeth with adjacent teeth that require RCT Previously root canal treated teeth Teeth with a history of trauma Teeth that have poor restorative prognosis Teeth requiring extensive prosthodontic rehabilitation Cracked teeth

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Permuted block randomization (of block size = only known to statistician) will be used to randomly select 212 subjects (106 subjects in each group). Statistical software (NCSS, LLC© ver. 2020) will be utilized to generate the randomization list and subjects will be assigned to the selected treatment group accordingly.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBO with calcium silicate sealer<br>The teeth will be obturated with the single cone technique and BC sealer | Device: TotalFill Bioceramic Sealer<br>* It will be used in conjunction with TotalFill® bioceramic impregnated gutta percha points for the obturation of root canals. It is dispensed through a fine disposable syringe into the root canals during obturation.<br>|
| Active Comparator: WVC with resin based sealer<br>The teeth will be obturated with warm vertical compaction and AH+ sealer | Device: AH+ Sealer<br>* It consists of 2 pastes that are mixed together in equal amounts before it is used in conjunction with gutta percha points for obturation during root canal treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of radiographic healing with periapical (PA) radiographs using Orstavik's PAI | Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C&S visits). Orstavik's periapical index (PAI) will be used as the outcome measure | Comparison of of periapical lesion size at baseline and 12 months | 
| Assessment of radiographic healing with Cone beam computed tomography (CBCT) scans using Estrela's PAI based on CBCT | Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C&S visits). Estrela's (periapical index) PAI based on CBCT will be used as outcome measure | Comparison of 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the postoperative pain score | 11 point Numerical Rating Scale (NRS) will be used. The participants will be given an NRS sheet to complete. They will be asked to choose a number between 0 'No Pain' and 10 'Worst imaginable pain' that best represents your pain intensity. | 1, 3 and 7 days postoperatively | 
| Comparison of the time required to complete obturation between the 2 groups |  | Intra-operatively |