Cost-efficacy of Silver Diammine Fluoride in Erupting Molars
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
30% silver diammine fluoride
Oral hygiene
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring dental caries, permanent teeth, silver diamine fluoride, tooth eruption
Eligibility 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, 3)
Exclusion Criteria:
- presence of cavitated caries lesions
- presence of enamel defects (hypoplasias)
Sites / Locations
- Universidade de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
30% silver diammine fluoride
cross-toothbrushing
Arm Description
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.
Children will be oriented to proceed cross-toothbrushing in erupting molars
Outcomes
Primary Outcome Measures
Caries progression
Secondary Outcome Measures
cost
patient's satisfaction
patient's discomfort
duration
Full Information
NCT ID
NCT01508611
First Posted
December 20, 2011
Last Updated
March 20, 2018
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01508611
Brief Title
Cost-efficacy of Silver Diammine Fluoride in Erupting Molars
Official Title
Cost-efficacy of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, permanent teeth, silver diamine fluoride, tooth eruption
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
30% silver diammine fluoride
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cross-toothbrushing
Arm Type
Active Comparator
Arm Description
Children will be oriented to proceed cross-toothbrushing in erupting molars
Intervention Type
Other
Intervention Name(s)
30% silver diammine fluoride
Other Intervention Name(s)
Cariestop, Biodinamica
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Oral hygiene
Other Intervention Name(s)
Toothbrush
Intervention Description
With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique
Primary Outcome Measure Information:
Title
Caries progression
Time Frame
12 months
Secondary Outcome Measure Information:
Title
cost
Time Frame
24 months
Title
patient's satisfaction
Time Frame
24 months
Title
patient's discomfort
Time Frame
24 months
Title
duration
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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, 3)
Exclusion Criteria:
presence of cavitated caries lesions
presence of enamel defects (hypoplasias)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana M Braga, PhD
Organizational Affiliation
USao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade de Sao Paulo
City
Sao Paulo
ZIP/Postal Code
55
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19341576
Citation
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.
Results Reference
background
PubMed Identifier
12407092
Citation
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. doi: 10.1177/0810767.
Results Reference
background
PubMed Identifier
17555173
Citation
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. doi: 10.2341/06-63.
Results Reference
background
PubMed Identifier
9643366
Citation
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. doi: 10.1159/000016460.
Results Reference
background
PubMed Identifier
17518963
Citation
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. doi: 10.1111/j.1600-0528.2007.00347.x.
Results Reference
background
PubMed Identifier
16040729
Citation
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. doi: 10.1177/154405910508400807.
Results Reference
background
PubMed Identifier
19641152
Citation
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.
Results Reference
background
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Cost-efficacy of Silver Diammine Fluoride in Erupting Molars
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