CompletedNot Applicable

Increasing Composite Restorations Sealants

Chile20 participantsStarted 2003-05

Plain-language summary

A cohort of 20 patients aged 18 to 80 years (mean 28.35 years) of both genres females (65%) and males (35%) with 80 composite restorations were recruited at the Operative Dentistry Clinic at the Dental School of the University of Chile. All participants presented with marginal adaptation clinical features that deviated from the ideal and were rated Bravo according to the modified United States Public Health Service (USPHS) criteria for the sealing group and no treatment group. As a positive control were considered composites with alpha values in marginal adaptation. The protocol was approved by the Institutional Research Ethics Committee of the Dental School at the University of Chile (Project PRI-ODO-0207). All of the patients signed informed-consent forms and completed registration form. The selection criteria are summarized below.

Who can participate

Age range

18 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: * Patients with localized marginal deficiencies (Bravo Ryge Criterial) of composite restorations that were clinically judged to be suitable for sealing according to USPHS criteria. * Patients with more than 20 teeth. * Restorations in functional occlusions with an opposing natural tooth. * Asymptomatic restored tooth. * At least one proximal contact area with a neighbouring tooth. * Patients are older than 18 years. * Patients who agreed and signed a consent form for participating in the study. * Area out of the restoration´s failure is in good condition. Inclusion Criteria for Positive Control group : * Composite resins with alpha value in adaptation marginal criterial Exclusion Criteria: * Patients with contra-indications for regular dental treatment based on their medical history. * Patients with xerostomia or taking medication that significantly decreased salivary flow. * Patients with a high risk of caries. * Patients with psychiatric or physical diseases, which interfered with oral hygiene. * Patients with localized marginal deficiencies \> 1 mm. and/or secondary caries adjacent to composite restorations , or major defects

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

Changes in quality of restorations

Timeframe: 1 year

Trial details

NCT IDNCT02119195

SponsorUniversity of Chile

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2003-05

View on ClinicalTrials.gov More Dental Restoration Failure trials