Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cost-efficacy of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.

Conditions
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Dental Caries

Intervention / Treatment
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* Other: 30% silver diammine fluoride
* Behavioral: Oral hygiene


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30% silver diammine fluoride<br>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. | Other: 30% silver diammine fluoride<br>* The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s. Anteroposterior toothbrushing technique will be explained to the children.<br>* Other names: Biodinamica;|
| Active Comparator: cross-toothbrushing<br>Children will be oriented to proceed cross-toothbrushing in erupting molars | Behavioral: Oral hygiene<br>* With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique<br>* Other names: Toothbrush;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries progression |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cost |  | 24 months | 
| patient's satisfaction |  | 24 months | 
| patient's discomfort |  | 24 months | 
| duration |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries, permanent teeth, silver diamine fluoride, tooth eruption