Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer (NCT03732170) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer
Singapore170 participantsStarted 2018-08-13
Plain-language 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.
Who can participate
Age range
21 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* A preoperative periapical radiograph will be required for diagnosis.
* Subjects at least 21 years old.
* Medically healthy
* In a patient with multiple teeth requiring root canal treatment, only 1 tooth from each side will be included and selected at random.
Exclusion Criteria:
* Patient below 21 years old
* Pregnant women.
* Patients with autoimmune diseases and uncontrolled diabetes.
* Teeth with periodontal probing depths of 5mm or more.
* Incomplete root formation that is detected radiographically.
* Cracked teeth
* Teeth are deemed to have poor restorative prognosis.
* Teeth with adjacent teeth on the same side that require root canal treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the status of periapical lesion size
Timeframe: comparison of the periapical lesion size at baseline, 6 month and 12 month