Treatment of Initial Caries Lesions on Proximal Surfaces of Primary and Permanent Posterior Teeth

Not Applicable

• Conditions: Compliance Behavior; Dental Caries
• Interventions: Procedure: Resin Infiltration; Procedure: 30% Silver Diammine Fluoride; Procedure: Dental Flossing; Procedure: Resin Infiltration Placebo; Procedure: 30% Silver Diammine Fluoride Placebo

• Registration Number: NCT01477385
• Lead Sponsor: University of Sao Paulo

Brief Summary

This study aims to evaluate the effectiveness of 30% silver diamine fluoride in the treatment of clinically caries lesions in enamel, with radiographic image restricted to the enamel or the outer third of dentin on the proximal surfaces of primary and permanent posterior teeth. It also aims to compare it to the resin infiltration and to the control of proximal biofilm through the oral hygiene.

Detailed Description

The sample will be comprised of 141 patients between 3 to 10 year-old and 504 proximal surfaces of 12-to-17-year-old adolescents, who present at least one proximal surface with initial caries lesion. Patients will be randomly allocated to treatments, according to the technique to be employed: (I) resin infiltration (II) 30% diamine silver fluoride, (III) just daily flossing by the patient. All subjects will receive placebo treatments performed in other groups. The teeth will be evaluated by clinical and radiographic exams at baseline and after 1, 3, 6, 12, 18 and 24 months. In 1, 3 and 18 months will just be evaluated aspects related to the biofilm.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Study Start: 2012-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

• Primary teeth: distal surface of the first molar, mesial surface of the second molar and distal surface of the second molar (when the first permanent molar is present) with initial caries lesion (ICDAS 1, 2 or 3).
• Permanent teeth: distal surface of the first premolar, mesial surface of the second premolar, distal surface of the second premolar, mesial surface of the first molar, distal surface of the first molar and mesial surface of the second molar with initial caries lesion (ICDAS 1, 2 or 3).

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Exclusion Criteria

• Mesial surface of the first primary molar/premolar by the smaller contact with the distal surface of the canines. It will be also excluded the surfaces that show proximal restorations, sealants, cavities, defects, as well as intact teeth.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin Infiltration	Dental Flossing	Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing
Resin Infiltration	30% Silver Diammine Fluoride Placebo	Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing
30% Silver Diammine Fluoride	Dental Flossing	30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing
Oral Hygiene	Dental Flossing	Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo
Oral Hygiene	30% Silver Diammine Fluoride Placebo	Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo
Oral Hygiene	Resin Infiltration Placebo	Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo
Resin Infiltration	Resin Infiltration	Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing
30% Silver Diammine Fluoride	30% Silver Diammine Fluoride	30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing
30% Silver Diammine Fluoride	Resin Infiltration Placebo	30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing

Primary Outcome Measures

Name	Time	Method
progression of initial lesion caries	12 and 24 months

Secondary Outcome Measures

Name	Time	Method
approximal plaque reduction	1, 3, 6, 12, 18 and 24 months

Trial Locations

Locations (1)

Universidade de São Paulo; 🇧🇷 São Paulo, Brazil