Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer
Condition: Root Canal Obturation
Study type: Interventional

Summary: 
      The study design is a double blinded randomized controlled trial and 170 subjects (teeth) ,
      85 in each of the 2 groups, will be enrolled from the patients at the NUH dental centre
      endodontic unit. The study aims to assess how the use of TotalFill® bioceramic sealer affects
      the healing outcome of apical periodontitis compared to a control AH plus®.

      Conventional root canal treatment will be done during this study. Radiographs will be taken
      at each study visit during the study for root canal. The preoperative, postoperative and
      review clinical and radiographic data will be analysed.
    

Detailed description: 
      Randomization and Blinding Study subject (tooth) will be randomized in a 1:1 allocation ratio
      between the two treatment groups. Allocation will be by random permuted block and stratified
      by gender to enhance balance. Computer generated randomized allocation for each subject will
      be concealed in opaque envelope. The envelope will only be opened by the operator on the
      obturation visit of the enrolled patient and the randomization number assigned to them.

      In the event that a patient has more than 1 tooth eligible for the study, only one tooth on
      left and/or right side of the mouth will be recruited for the study. Therefore, a patient
      could contribute a maximum of two teeth for this study (i.e. a maximum of one tooth on each
      side of the mouth). Selection of tooth will be done using computer generated randomization
      number.

      Study Visits and Procedures After cleaning and shaping and the patients are deemed ready for
      obturation, the patients will be randomly assigned to one of the 2 groups for obturation
      using AH plus® or TotalFill® bioceramic sealer.

        -  The patients and the examiners will be blinded to the type of sealer used but it would
           not be possible to blind the operators.

           b. Post Study Follow up and Procedures

        -  A follow up phone call will be made to collect the patient pain experience on day 1, day
           3 and day 7 post treatment which they have recorded on their pain/discomfort diary.

        -  At the 6-month and 12-month review, patients will be examined for any clinical signs and
           symptoms and a review radiograph will be taken to assess the size of the periapical
           lesion.

           c. Radiographic assessment

        -  All radiographs will be taken with a localising device to control for angulation and
           magnification.

        -  Calibrated measurement tools in the dental practice management software will be used to
           measure the diameter of the lesion across the longest diameter.

      Statistical and Analytical Plans

      a. General Considerations Intention-to-treat population is considered the main analysis
      population. The intention-to-treat population includes all subjects who were assigned a
      randomization number. Study subject's demographic and pre-operative characteristics will be
      summarized for each treatment group.
    

Intervention name(s): TotalFill® Bioceramic sealer; AH plus® sealer
Intervention type(s): Device; Device
Intervention description(s): The participant will be treated with TotalFill® Bioceramic sealer.; The participant will be treated with AH plus® sealer.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment