Cost-efficacy of Silver Diammine Fluoride in Erupting Molars
1 other identifier
interventional
192
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 12, 2012
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 21, 2018
March 1, 2018
3.5 years
December 20, 2011
March 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Caries progression
12 months
Secondary Outcomes (4)
cost
24 months
patient's satisfaction
24 months
patient's discomfort
24 months
duration
24 months
Study Arms (2)
30% silver diammine fluoride
ACTIVE COMPARATORThe 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
ACTIVE COMPARATORChildren will be oriented to proceed cross-toothbrushing in erupting molars
Interventions
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.
With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- presence of cavitated caries lesions
- presence of enamel defects (hypoplasias)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade de Sao Paulo
São Paulo, 55, Brazil
Related Publications (7)
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.
PMID: 19341576BACKGROUNDChu 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. doi: 10.1177/0810767.
PMID: 12407092BACKGROUNDEkstrand 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. doi: 10.2341/06-63.
PMID: 17555173BACKGROUNDEkstrand 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. doi: 10.1159/000016460.
PMID: 9643366BACKGROUNDIsmail 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. doi: 10.1111/j.1600-0528.2007.00347.x.
PMID: 17518963BACKGROUNDLlodra 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. doi: 10.1177/154405910508400807.
PMID: 16040729BACKGROUNDYee 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.
PMID: 19641152BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariana M Braga, PhD
USao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, Associate Professor
Study Record Dates
First Submitted
December 20, 2011
First Posted
January 12, 2012
Study Start
February 1, 2015
Primary Completion
August 1, 2018
Study Completion
August 1, 2019
Last Updated
March 21, 2018
Record last verified: 2018-03