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

U

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

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

Trial contacts and locations

1

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Central trial contact

Mariana M Braga, PhD

Data sourced from clinicaltrials.gov

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