Outcome of SBO With Calcium Silicate Sealer vs WVC With Resin Based Sealer
Condition: Root Canal Obturation; Root Canal Filling; Sealer-based Obturation; Randomized Clinical Trial; Postoperative Pain; Resin Based Sealer; Warm Vertical Compaction
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): TotalFill Bioceramic Sealer; AH+ Sealer
Intervention type(s): Device; Device
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment