Cost-effectiveness of Silver Diammine Fluoride to Control Caries Lesions

This study is not yet open for participant recruitment.

Verified January 2012 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: January 9, 2012

Last verified: January 2012

History of Changes

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: Treatment
Official Title:	Cost-effectiveness of Silver Diammine Fluoride to Control Caries Lesions in Erupting Permanent First Molars - Randomized Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Dental Health Tooth Decay

Drug Information available for: Fluorine Fluoride

U.S. FDA Resources

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 ]

Estimated Enrollment:	100
Study Start Date:	February 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 30% silver diammine fluoride	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 100 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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

erupting permanent molars (that are not in full occlusion)
not special children

Exclusion Criteria:

presence of cavitated caries lesions
presence of enamel defects (hypoplasias)

Contacts and Locations

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

Contacts

Contact: Mariana M Braga, PhD

55 11 30917835

mmbraga@usp.br

Locations

Brazil
Universidade de Sao Paulo	Not yet 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

Sponsors and Collaborators

University of Sao Paulo

Investigators

Principal Investigator:

Mariana M Braga, PhD

USao Paulo

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

Responsible Party:	Mariana Minatel Braga, PhD, Senior lecturer, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01508611 History of Changes
Other Study ID Numbers:	03
Study First Received:	December 20, 2011
Last Updated:	January 9, 2012
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013

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