Effectiveness of Sealing Dental Caries

Status Active, not recruiting

Clinical Trial Summary

This study aims to evaluate, through a controlled clinical randomized study, the effectiveness of sealing carious lesions with composite resin in primary molars. For this, healthy children (n=100) with caries lesion reaching to the middle third of the dentin of primary molars, will be submitted to different treatments to remove the lesions. These patients will be randomly allocated in the following treatment groups: (1) cavity sealing (Non-invasive resin based dental sealing) without caries removal; and (2) Partial caries removal and Invasive resin based restoration. The clinical and radiographic success of the treatment groups will be verified by periodic examination of the restorations by USPHS criteria and radiographic subtraction, respectively, which will be checked progression or not of injury. The researcher responsible for these assessments will be blind to the study, whose evaluations will occur after 6, 12, 24 and 36 months of treatment.

Clinical Trial Description

The present study will be carried out as a randomized clinical study. Primary, occlusal caries lesions in children, aged 3-8 years old will be treated by non-invasive resin based sealing (n= 50) or resin based restoration (n=50). Randomization between sealing and restoration (1:1) was made by for a resercher at the Federal University of Rio de Janeiro and kept at the clinics in sealed envelopes. The treatments will be examined clinically and radiographically after 6, 12, 24 and 36 years. The treatments are performed and controlled by only one practitioner (the main reseacher of this study) from the Federal University of Rio de Janeiro, Brazil.

Sealing: The dentist will use a resin based sealing, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from the Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.

Restoration: The dentist will use preparation design and a resin based resin restoration, and follow their usual clinical procedures (partial caries removal) based on the instructions from the manufacturer and the guidelines from Department of Pediatric Dentistry and Orthodontics of Federal University of Rio de Janeiro, Brazil.

The prevalence of regression, arrest and progression of sealed and restored caries lesions, are computed and related to the clinical and radiological registrations of children, or treatment related factors for assessing of statistically significant correlations.

The influence of each factor on the longevity and need for retreatment of occlusal sealants and restorations, will be assessed using apropriate analyses for statistical treatment of data. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Dental Caries

Clinical Trial Details

NCT number	NCT02584218
Study type	Interventional
Source	Universidade Federal do Rio de Janeiro
Contact
Status	Active, not recruiting
Phase	N/A
Start date	January 2015
Completion date	February 2017

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