Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: 30% silver diammine fluoride; Behavioral: Oral hygiene

• Registration Number: NCT01508611
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Study Start: 2015-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-21
• Primary Completion: 2018-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30% silver diammine fluoride	30% silver diammine fluoride	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.
cross-toothbrushing	Oral hygiene	Children will be oriented to proceed cross-toothbrushing in erupting molars

Primary Outcome Measures

Name	Time	Method
Caries progression	12 months

Secondary Outcome Measures

Name	Time	Method
duration	24 months
cost	24 months
patient's satisfaction	24 months
patient's discomfort	24 months

Trial Locations

Locations (1)

Universidade de Sao Paulo; 🇧🇷 Sao Paulo, Brazil