Clinical Efficiency of Bioactive Pit and Fissure Sealant (NCT06493942) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Clinical Efficiency of Bioactive Pit and Fissure Sealant
40 participantsStarted 2024-08-01
Plain-language summary
This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
Who can participate
Age range
6 Years – 10 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:
* Inclusion Criteria of participants:
* Patients with caries susceptible fiss- ures in fully erupted first permanent molars showing nosigns of caries.
* Co-operative patients approving to part- icipate in the trial.
* Good oral hygiene.
* Inclusion Criteria of teeth:
* Caries susceptible occlusal pits and fissures.
* Intact contact with opposing teeth.
* Teeth with no previous restorations in other surfaces.
Exclusion Criteria:
* Exclusion criteria of participants:
* patients with Disabilities, systemic disease or severe medical complications.
* patients have allergic history concerning methacrylate.
* patients with rampant caries, xerostomia, evidence of severe bruxism, clenching, or tempromandibular joint disorders
* participants who show lack of compliance.
* Exclusion criteria of teeth:
* Carious pits and fissures.
* Developmental tooth defect.
* Partially erupted teeth
* Periapical pathology or signs of pulpal pathology.
* Tooth hypersensitivity.
* Heavy occlusion and occlusal contacts.
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.