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

NCT02293304 | Unknown

• 1 other identifier: TLenzi
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Self-etch approach

EXPERIMENTAL

Application of universal adhesive as self-etch mode

Other: Self-etch approach

Etch-and-rinse approach

EXPERIMENTAL

Application of universal adhesive as etch-and-rinse mode

Other: Etch-and-rinse approach

Interventions

Self-etch approach OTHER

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.

Self-etch approach

Etch-and-rinse approach OTHER

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.

Etch-and-rinse approach

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Santa Maria: lead

Study Sites (1)

Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, 97015372, Brazil

RECRUITING

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rachel Rocha, Professor

  Universidade Federal de Santa Maria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Rocha, Professor

CONTACT

+55 55 3220 9266; rachelrocha@smail.ufsm.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rachel de Oliveira Rocha

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 18, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: July 1, 2016
• Last Updated: November 18, 2014

Record last verified: 2014-11

Locations

BR (1)