Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant (NCT05336162) | Clinical Trial Compass
UnknownNot Applicable
Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant
Egypt30 participantsStarted 2023-01-25
Plain-language summary
With limited evidence-based information in literature about using giomer based pit and fissure sealant(BeautiSealant) in non-cavitated pits and fissures in permanent molars, it is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new pit and fissure sealant (BeautiSealant, Shoufu, USA). will have the same effect as resin based pit and fissure sealant (UltraSeal XT™ plus, Ultradent, USA) regarding retention rate and caries preventive effect.
Who can participate
Age range
16 Years – 22 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:
* Young adults (16-22 y).
* Patients who have existing pits and fissures that are anatomically deep and caries susceptible.
* Permanent molars teeth without any caries and cavitation.
* Permanent molar teeth that have deep pit and fissure morphology, with "sticky" fissures. •Permanent molar teeth with stained grooves.
* Stained pits and fissures with minimum decalcification of opacification and no softness at the base of the fissure (ICDAS 1 and 2).
Exclusion Criteria:
* Uncooperative behavior, limits the use of sealants due to hampering of adequate field or isolation techniques throughout the procedure.
* Patients allergic to sealant material.
* Patient with history of medical disease, drug therapies or any other serious relevant problem.
* An individual with no previous caries experience and well coalesced pits and fissures
* Partially erupted teeth.
* Teeth with cavitation or caries of the dentin.
* A large restoration is present on occlusal Surface.
* If pits and fissures are self-cleansable.
* Teeth with dental fluorosis, hypocalcification or hyper calcification.
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.