Effectiveness of Sealing Dental Caries

NCT ID: NCT02584218

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-02-28

Brief 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.

Detailed 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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Non-invasive resin based caries sealing

Application of resin based sealant after acid etching of carious occlusal surface

Group Type: EXPERIMENTAL

Non-invasive resin based caries sealing

Intervention Type: PROCEDURE

The dentists use resin based sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil

Invasive resin based restoration

Application of resin based resin restoration after operative intervention of caries lesion, excavation and preparation on occlusal surface

Group Type: ACTIVE_COMPARATOR

Invasive resin based restoration

Intervention Type: PROCEDURE

The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil

Interventions

Non-invasive resin based caries sealing

The dentists use resin based sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil

Intervention Type: PROCEDURE

Invasive resin based restoration

The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil

Intervention Type: PROCEDURE

Other Intervention Names

Sealing dental caries; Restoration

Eligibility Criteria

Inclusion Criteria

• Children with good general health; children with caries lesion reaching to the middle third of the dentin of primary molars

Exclusion Criteria

• Patients with systemic diseases; patient' guardians who did not consent with the study.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Káiron Ribeiro Dias

Postgraduate student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AGA-0001

Identifier Type: -

Identifier Source: org_study_id