CompletedPhase 3

"Comparative Clinical Evaluation of Pit and Fissure Sealants on Permanent First Molar Teeth in Children."

India42 participantsStarted 2021-04-02

Plain-language summary

Study was aimed to evaluate and compare clinical efficacy of the Microfilled resin sealant, Nanofilled resin sealant, Flowable composite as sealant, with Unfilled resin sealant on first permanent molar in children at 9 months follow ups. Children (age 7 to 10) with deep pits and fissures, (ICDAS 0-2) included in the study and study was Split mouth randomized controlled clinical trial. Sample size- Total number of 42 patients will be recruited in the study, with 42 first permanent molars in each group. Methods-Patients were seated in supine position on the dental chair and cotton rolls will be applied for isolation. The first permanent molar in each group was treated as follows: Group 1 -Intervention with Microfilled resin sealant. Group 2- ¬Intervention with Nanofilled resin sealant. Group 3 -Intervention with Flowable composite as sealant. Group 4 - ¬Intervention with Unfilled resin sealant. Patients and their parents were received instructions for daily brushing and oral hygiene maintenance. Sealant clinical efficacy was evaluated at 3, 6 and 9 month recall visit. OUTCOME MEASURES: 1. Primary outcomes: To evaluate sealant retention, anticaries effect and marginal integration. 2. Secondary outcomes: to evaluate, colour change and surface roughness of sealant.

Who can participate

Age range

7 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

. Normal healthy children aged 7 to 10 years.
. Subjects who are not undergoing any other preventive dental health treatment.
. Availability for the duration of the study.
. Satisfactory dental care performed at home.
. The willingness of the patient to accept the treatment.
. All four first permanent molars that have completely erupted with deep pits and fissures.
. Fissures either intact, sound or retentive which are stained, caries free or ICDAS 0-2.

Exclusion criteria

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

To evaluate sealant retention

Timeframe: 9 months

Trial details

NCT IDNCT05791682

SponsorPostgraduate Institute of Dental Sciences Rohtak

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-03

View on ClinicalTrials.gov More PITS AND FISSURE SEALANT trials