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

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.

Study Overview

• Status: Unknown
• Conditions: Dental Caries
• Intervention / Treatment: Other: Self-etch approach; Other: Etch-and-rinse approach

Detailed Description

Randomized clinical trials of performance of universal adhesive in primary molars

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Rocha, Professor; Phone Number: +55 55 3220 9266; Email: rachelrocha@smail.ufsm.br

Study Locations

• Brazil
  • Rio Grande do Sul
    • Santa Maria, Rio Grande do Sul, Brazil, 97015372
      • Recruiting
      • Federal University of Santa Maria
      • Contact: Tathiane Lenzi, PhD; Phone Number: +55 55 3220 9266; Email: tathilenzi@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-etch approach; Application of universal adhesive as self-etch mode	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.
Experimental: Etch-and-rinse approach; Application of universal adhesive as etch-and-rinse mode	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longevity of restoration	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.	18-month follow up

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Maria
• Investigators: Principal Investigator: Rachel Rocha, Professor, Universidade Federal de Santa Maria

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: TLenzi