Efficacy and Retention of Sealants Placement Using Two Isolation Systems (NCT05749991) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Retention of Sealants Placement Using Two Isolation Systems
Kuwait65 participantsStarted 2018-06-03
Plain-language summary
The trial aimed to evaluate the sealant retention, patient's preference and chair time needed during pit and fissure sealant placement under two isolation techniques \[Dryshield system (DS) and cotton roll isolation (CRI)\] in a university setting.
Who can participate
Age range
6 Years – 12 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
. Healthy patients with no compromising medical or physical condition
. age ranging from six to 12 years old;
. patients with at least one caries-free permanent molar in any quadrant, with normal anatomy, who qualified for pit and fissure sealant application with an International Caries Detection and Assessment System (ICDAS) score of 0-2.
. no prior sealants or restorations on the teeth under study;
. no cavitated carious lesions;
. cooperative patients (classified as 3 or 4 according to the Frankl Behavioral Rating Scale)
. legal guardian consents and approved assents to the child's participation in the study.
Exclusion criteria
. a history of chronic disease (e.g., epilepsy, ectodermal dysplasia, cardiac anomalies);
. inability to return for follow-ups.
. patients with molars that have partially erupted
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 Fissure Sealant Retention at 6 months
Timeframe: Change in sealant retention at 6 months
2
Change in Fissure Sealant Retention at 12 months
Timeframe: Change in sealant retention at 12 months
3
Change in Fissure Sealant Retention at 18 months
Timeframe: Change in sealant retention at 18 months