UnknownNot Applicable

Retention of a Flowable Resin-based Sealant With Two Types of Adhesives

Peru50 participantsStarted 2021-06

Plain-language summary

The aim of the present study is to compare the use of two adhesives for the placement of occlusal sealants, evaluating their retention on the occlusal surfaces. Methods: A randomized clinical trial, in Phase IV, triple-blind, with a split mouth study design will be adopted, which consists of a simple division of the mouth into two parts (right and left) for the first four permanent molars of each patient, where the placement of the materials will be on the right / left side of the mouth and contralateral. They will then be randomly assigned following block randomization procedures with a 1: 1 allocation. 50 participants (6-year-old children) will be considered, and a pair of permanent first molars homologs will be used for each participant. Inclusion criteria include: children whose parents accepted their participation in the study and who signed the Informed Consent, children enrolled in the Pichanaki District school, children who present upper and / or lower permanent molars with absence of deep caries cavities and caries, graded 0 and 1 according to ICDAS II, Green and Vermillion Simplified Oral Hygiene Index of 1-2, have a pair of non-cavitated caries-free counterparts, and children with positive behavior. After selection of patients, the dental sealants will be placed with two different adhesives: the 8th generation adhesive intervention group (Scotchbond universal 3M) and the 5th generation adhesive control group (Single bond 3M), both sealants will use the same flowable resin (Tetric N-flow ivoclar vivadent). Results evaluation: Retention of the sealants will be evaluated at 6, 9 and 12 months. Retention rates of pit and fissure sealant materials will be analyzed according to the split mouth design. The study will use the Mc Nemar test to compare the retention of sealants in the intervention group and the control group at 6, 9 and 12 months. A 95% confidence level will be accepted. In addition, the Cochrane Q test will be applied to determine if there are significant differences in survival for each group of sealants through the evaluation time. The calculation of the survival months of the sealants will be carried out using the actuarial method (survival tables). Expected conclusion: To identify which of the two adhesives presents the best retention after 12 months.

Who can participate

Age range

72 Months – 83 Months

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: * Children whose parents accepted their participation in the study and who signed the Informed Consent * Children enrolled in the Pichanaki District school, Chanchamayo province, in Junin department 6-year-old children, who present upper and / or lower permanent molars with the following characteristics: * Absence of deep caries cavities and caries, graded 0 and 1 according to ICDAS II * Green and Vermillion Simplified Oral Hygiene Index (OHI) of 1-2 * Have a pair of non-cavitated caries-free counterparts. * Children with positive behavior. Exclusion Criteria: * Children with the presence of a deep dental caries lesion, with pulp exposure, history of pain and presence of fistula or abscess adjacent to decayed tooth. • Medically compromised children * Children with developmental enamel defects. * Children with a known allergy to any of the resins used * Children with previously placed sealants or restorations * Children residing outside the city

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

Clinical Retention of adhesives

Timeframe: 12 months

Trial details

NCT IDNCT04945382

SponsorNational University of San Marcos, Peru

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07

Contact for this trial

Gilmer Torres Ramos

01 993161289 gtorresr@unmsm.edu.pe

View on ClinicalTrials.gov More Caries,Dental trials