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Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01508611
Enrollment
192
Registered
2012-01-12
Start date
2015-02-28
Completion date
2019-08-31
Last updated
2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

dental caries, permanent teeth, silver diamine fluoride, tooth eruption

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.

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.

BEHAVIORALOral hygiene

With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Caries progression12 months

Secondary

MeasureTime frame
cost24 months
patient's satisfaction24 months
patient's discomfort24 months
duration24 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026