Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

March 20, 2018 updated by: Mariana Minatel Braga, University of Sao Paulo

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 55
        • Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 7 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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:
  • Cariestop
  • Biodinamica
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:
  • Toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Caries progression
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
cost
Time Frame: 24 months
24 months
patient's satisfaction
Time Frame: 24 months
24 months
patient's discomfort
Time Frame: 24 months
24 months
duration
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Mariana M Braga, PhD, USao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2019

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

January 9, 2012

First Posted (ESTIMATE)

January 12, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDFtrials-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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