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Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

U

University of Sao Paulo

Status

Unknown

Conditions

Dental Caries

Treatments

Other: 30% silver diammine fluoride
Behavioral: Oral hygiene

Study type

Interventional

Funder types

Other

Identifiers

NCT01508611
SDFtrials-02

Details and patient eligibility

About

This study aims to evaluate the cost-effectiveness of 30% silver diammine fluoride in the treatment of clinically caries lesions in enamel, on occlusal surfaces in first permanent molars compared to a control group that performs only the cross-toothbrushing technique and evaluate the acceptability and satisfaction of patients and responsible for the application of the solution cariostatic.

Full description

The sample will be comprised of 183 patients between 4 to 7 year-old, who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3). Patients will be randomly allocated to treatments, according to the technique to be employed: (I) 30% diamine silver fluoride, (II) cross-toothbrushing technique. Will also be guided and motivated individual, where these children will be taught the technique of brushing conventional. It will be given to all patients a toothbrush. In times of reassessment, the degree of wear of the bristles of these brushes will be evaluated in order to infer the use of the same. The teeth will be evaluated by clinical and exams at baseline and after 3, 6, 12, 18 and 24 months.

Enrollment

192 patients

Sex

All

Ages

4 to 7 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • erupting permanent molars (that are not in full occlusion)
  • not special children
  • children who present at least occlusal surface with initial caries lesion (ICDAS 1, 2, 3)

Exclusion criteria

  • presence of cavitated caries lesions
  • presence of enamel defects (hypoplasias)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

192 participants in 2 patient groups

30% silver diammine fluoride
Active Comparator group
Description:
The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied in erupting molars with a disposable microbrush for 3m. Then the surface will be washed for 30s.
Treatment:
Other: 30% silver diammine fluoride
cross-toothbrushing
Active Comparator group
Description:
Children will be oriented to proceed cross-toothbrushing in erupting molars
Treatment:
Behavioral: Oral hygiene

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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