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

University of Sao Paulo

Status: Unknown

Conditions: Dental Caries; Compliance Behavior

Treatments: Procedure: Resin Infiltration; Procedure: Dental Flossing; Procedure: 30% Silver Diammine Fluoride Placebo; Procedure: Resin Infiltration Placebo; Procedure: 30% Silver Diammine Fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT01477385

SDFtrials-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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183 participants in 3 patient groups

Resin Infiltration

Active Comparator group

Description:

Resin Infiltration 30% Silver Diammine Fluoride Placebo Dental Flossing

Treatment:

Procedure: 30% Silver Diammine Fluoride Placebo

Procedure: Dental Flossing

Procedure: Resin Infiltration

30% Silver Diammine Fluoride

Experimental group

Description:

30% Silver Diammine Fluoride Resin Infiltration Placebo Dental Flossing

Treatment:

Procedure: 30% Silver Diammine Fluoride

Procedure: Resin Infiltration Placebo

Procedure: Dental Flossing

Oral Hygiene

Active Comparator group

Description:

Dental Flossing 30% Silver Diammine Fluoride Placebo Resin Infiltration Placebo

Treatment:

Procedure: Resin Infiltration Placebo

Procedure: 30% Silver Diammine Fluoride Placebo

Procedure: Dental Flossing