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 range18 Years

SexALL

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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

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