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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
The participant will be treated with TotalFill® Bioceramic sealer.
The participant will be treated with AH plus® sealer.
National University Hospital, Singapore
Singapore, Singapore
Change in the status of periapical lesion size
Proportion z-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).
Time frame: comparison of the periapical lesion size at baseline, 6 month and 12 month
Comparison of the pain score of post-op pain
Proportion z-test will be carried out. The odds ratio with a 95% confidence interval will be reported. A two-sample t-test will be performed to access the change in pain score (Pain was recorded as "no pain" (score = 0) or a 5-point Likert scale ranging from very mild pain (score = 1) to severe pain (score = 5)) at post-op compared with pre-op between the two treatment groups. Shapiro Wilk's test and Levene's test will be performed to check the normality and homogenous variance assumption of the two-sample t-test. Non-parametric approach (Mann-Whitney U-test) will be employed if there is significant violations of the normality assumption.
Time frame: Day 1, Day 3 and Day 7 post treatment
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