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

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: Etch-and-rinse approach; Other: Self-etch approach

• Registration Number: NCT02293304
• Lead Sponsor: Universidade Federal de Santa Maria

Brief 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.

Detailed Description

Randomized clinical trials of performance of universal adhesive in primary molars

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study First Submitted: 2014-11-10
• Study First Submitted QC: 2014-11-13
• Last Update Submitted: 2014-11-13
• Study First Posted: 2014-11-18
• Last Update Posted: 2014-11-18
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• active carious lesion in middle dentin limited to the occlusal or occluso-proximal surfaces of primary molars;
• children (male or female) in good general health.

Exclusion Criteria

• children who refuse or fail to cooperate with the completion of clinical procedure; - teeth without antagonist;
• carious lesions in inner half of dentin;
• presence of painful symptoms or signs of pulpal changes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etch-and-rinse approach	Etch-and-rinse approach	Application of universal adhesive as etch-and-rinse mode
Self-etch approach	Self-etch approach	Application of universal adhesive as self-etch mode

Primary Outcome Measures

Name	Time	Method
Longevity of restoration	18-month follow up	The outcome of the study is the failure of restorations in primary teeth. Failures will be assessed by clinical evaluation and will be considered in the presence of loss of restoration or fracture requiring a reintervation (restoration repair or replacement) or symptoms requiring pulp intervention or tooth extraction.

Trial Locations

Locations (1)

Federal University of Santa Maria; 🇧🇷 Santa Maria, Rio Grande do Sul, Brazil