Cost-efficacy of Silver Diammine Fluoride in Erupting Molars
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
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.
Other Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Caries progression [12 months]
Secondary Outcome Measures
- cost [24 months]
- patient's satisfaction [24 months]
- patient's discomfort [24 months]
- duration [24 months]
Eligibility Criteria
Criteria
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,
Exclusion Criteria:
-
presence of cavitated caries lesions
-
presence of enamel defects (hypoplasias)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universidade de Sao Paulo | Sao Paulo | Brazil | 55 |
Sponsors and Collaborators
- University of Sao Paulo
Investigators
- Principal Investigator: Mariana M Braga, PhD, USao Paulo
Study Documents (Full-Text)
None provided.More Information
Publications
- Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009 Jan-Apr;76(1):28-33.
- Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70.
- Ekstrand KR, Martignon S, Ricketts DJ, Qvist V. Detection and activity assessment of primary coronal caries lesions: a methodologic study. Oper Dent. 2007 May-Jun;32(3):225-35.
- Ekstrand KR, Ricketts DN, Kidd EA, Qvist V, Schou S. Detection, diagnosing, monitoring and logical treatment of occlusal caries in relation to lesion activity and severity: an in vivo examination with histological validation. Caries Res. 1998;32(4):247-54.
- Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8.
- Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4.
- Yee R, Holmgren C, Mulder J, Lama D, Walker D, van Palenstein Helderman W. Efficacy of silver diamine fluoride for Arresting Caries Treatment. J Dent Res. 2009 Jul;88(7):644-7. doi: 10.1177/0022034509338671.
- SDFtrials-02