Cost-effectiveness of Silver Diammine Fluoride in Erupting Molars
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Cost-effectiveness of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.|
- Caries progression [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- cost [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- patient's satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- patient's discomfort [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: 30% silver diammine fluoride||
Other: 30% silver diammine fluoride
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.
Active Comparator: cross-toothbrushing
Children will be oriented to proceed cross-toothbrushing in erupting molars
Behavioral: Oral hygiene
With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique
Other Name: Toothbrush
The sample will be comprised of 100 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508611
|Contact: Mariana M Braga, PhD||55 11 firstname.lastname@example.org|
|Universidade de Sao Paulo||Not yet recruiting|
|Sao Paulo, Brazil, 55|
|Contact: Mariana M Braga, PhD 55 11 30917835 email@example.com|
|Principal Investigator: Mariana M Braga, PhD|
|Sub-Investigator: Andrezza M Matthiesen, DDS|
|Principal Investigator:||Mariana M Braga, PhD||USao Paulo|