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

Universidade Federal de Santa Maria

Status: Unknown

Conditions: Dental Caries

Treatments: Other: Self-etch approach; Other: Etch-and-rinse approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02293304

TLenzi

Details and patient eligibility

About

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.

Full description

Randomized clinical trials of performance of universal adhesive in primary molars

Enrollment: 132 estimated patients

Sex: All

Ages: 5 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

Self-etch approach

Experimental group

Description:

Application of universal adhesive as self-etch mode

Treatment:

Other: Self-etch approach

Etch-and-rinse approach

Experimental group

Description:

Application of universal adhesive as etch-and-rinse mode

Treatment:

Other: Etch-and-rinse approach