Cost-efficacy of Silver Diammine Fluoride in Erupting Molars

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Mariana Minatel Braga, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01508611
First received: December 20, 2011
Last updated: May 25, 2016
Last verified: May 2016
  Purpose
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 Intervention
Dental Caries
Other: 30% silver diammine fluoride
Behavioral: Oral hygiene

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cost-efficacy of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Caries progression [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • cost [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • patient's satisfaction [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • patient's discomfort [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • duration [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 183
Study Start Date: February 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Toothbrush

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.
  Eligibility

Ages Eligible for Study:   4 Years to 7 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508611

Contacts
Contact: Mariana M Braga, PhD 55 11 30917835 mmbraga@usp.br
Contact: Luciana P Antonio, DDS 11-999092090 lucianapion@usp.br

Locations
Brazil
Universidade de Sao Paulo Recruiting
Sao Paulo, Brazil, 55
Contact: Mariana M Braga, PhD    55 11 30917835    mmbraga@usp.br   
Principal Investigator: Mariana M Braga, PhD         
Sub-Investigator: Andrezza M Matthiesen, DDS         
Sub-Investigator: Luciana P Antonio, DDS         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Mariana M Braga, PhD USao Paulo
  More Information

Publications:

Responsible Party: Mariana Minatel Braga, PhD, Associate Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01508611     History of Changes
Other Study ID Numbers: SDFtrials-02 
Study First Received: December 20, 2011
Last Updated: May 25, 2016
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
dental caries
permanent teeth
silver diamine fluoride
tooth eruption

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2016