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

NCT ID: NCT02293304

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Randomized clinical trials of performance of universal adhesive in primary molars

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Self-etch approach

Application of universal adhesive as self-etch mode

Group Type EXPERIMENTAL

Self-etch approach

Intervention Type 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.

Etch-and-rinse approach

Application of universal adhesive as etch-and-rinse mode

Group Type EXPERIMENTAL

Etch-and-rinse approach

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidade Federal de Santa Maria

OTHER

Sponsor Role lead

Responsible Party

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Rachel de Oliveira Rocha

Rachel de Oliveira Rocha

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Rocha, Professor

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Maria

Locations

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Federal University of Santa Maria

Santa Maria, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Rachel Rocha, Professor

Role: CONTACT

[email protected]
+55 55 3220 9266

Facility Contacts

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Tathiane Lenzi, PhD

Role: primary

[email protected]
+55 55 3220 9266

Other Identifiers

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TLenzi

Identifier Type: -

Identifier Source: org_study_id