A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Ret… (NCT07399340) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Comparative Evaluation of the Role of Self-Adhesive Flowable Composite in Enhancing Sealant Retention Versus Conventional Pits and Fissure Sealant With and Without Fissurotomy in Permanent Molars
Egypt88 participantsStarted 2026-03
Plain-language summary
This RCT study aims to establish evidence-based decision comparing between self-adhering flowable composite Vertise™ Flow (Kerr, Orange, CA, USA) and conventional resin-based pits \& fissure sealant Helioseal-F sealant (Ivoclar Vivadent AG, Schaan, Liechtenstein) with and without fissurotomy in sealant retention and prevention of occlusal pits and fissures caries in first permanent molars over a 12-month follow-up.
Who can participate
Age range
6 Years – 8 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:
* Normal healthy children aged 6 to 8 years.
* Children with high caries risk
* Completely erupted lower first permanent molars with deep pits and fissures.
* Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.
* Availability for the duration of the study.
* Satisfactory dental care performed at home.
Exclusion Criteria:
* Children whose parents refuse to sign informed consent.
* Long-term medication affecting the salivary flow.
* Children enrolled for other studies or fluoridation program.
* Adverse reaction reported to any dental material.
* Uncooperative child.
* Bruxism or malocclusion.
* Children with developmental defects/ hypoplastic molars or caries affected teeth (ICDAS\>2).
* Teeth with restoration and partially retained sealants.
* Children who cannot come for the follow-up.
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.