Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars (NCT06729788) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Resin Infiltrate as Pit and Fissure Sealant in Permanent Molars
Egypt86 participantsStarted 2025-01-04
Plain-language summary
The aim of this study is to evaluate and compare the clinical effectiveness of ICON resin Infiltration versus conventional sealant and the microleakage and penetration depth of the two sealant materials.
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
. Age of the children from 6 to 8 years.
. Healthy children free from any systemic disease.
. Show bilaterally sound fully erupted lower first permanent molars with deep narrow central fissures and supplemental grooves.
. The eruption time of these molars should not exceed 3 years.
. No sign of pain or active periodontal disease in the selected teeth.
Exclusion criteria
. Children with fillings or sealants in the selected teeth.
. Children with clinical evidence of caries in the selected teeth either white spot lesions or cavities.
. Children with an allergy to any drug, such as resin restorative material.
. Children with Extremely poor oral hygiene.
. Hypoplastic teeth.
. Children with bruxism.
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
Evaluate the clinical effectiveness of ICON resin and the sealant retention using Simonsen's criteria.
Timeframe: 3 minutes for application of ICON. The children will be recalled at 3, 6, and 9 months