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Performance of Universal Adhesive in Primary Molars: a Randomized Clinical Trial

NCT02293304 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2014-11-18

No results posted yet for this study

Summary

The aim of this study is to evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, 3M ESPE, St Paul, MN, USA) in primary molars after partial carious removal. This randomized clinical trial will include subjects (5-10 year-old children) selected at two university centers (UFSM and FOUSP). The sample will consist of 132 primary molars presenting active cavitated carious lesions (with radiographic involvement of the outer half of the dentin), located on the occlusal and occlusal-proximal surface. The sample will be randomly divided into two groups according to bonding approach: etch-and-rinse or self-etch strategy. The restorations will be clinically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation. Survival estimates for restoration longevity will be evaluated using the Kaplan-Meier method.

Conditions

  • Dental Caries

Interventions

OTHER

Self-etch approach

The adhesive will be vigorously agitated on the entire enamel and dentin surfaces for 20 seconds, according to the manufacturer's recommendations.The brush will be scrubbed on the dentin surface under manual pressure followed by gentle air thinning for five seconds and finally light curing for 10 seconds.

OTHER

Etch-and-rinse approach

After acid etching for 15 seconds, the sound and caries-affected dentin will be kept moist.The adhesive will be vigorously agitated on the entire enamel and dentin surfaces for 20 seconds, according to the manufacturer's recommendations.The brush will be scrubbed on the dentin surface under manual pressure followed by gentle air thinning for five seconds and finally light curing for 10 seconds.

Sponsors & Collaborators

  • Universidade Federal de Santa Maria

    lead OTHER

Principal Investigators

  • Rachel Rocha, Professor · Universidade Federal de Santa Maria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-11-30
Completion
2016-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293304 on ClinicalTrials.gov