Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
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ClinicalTrials.gov Identifier: NCT03063307
Recruitment Status : Unknown
Verified October 2017 by Ana Lúcia Vollú, Universidade Federal do Rio de Janeiro. Recruitment status was: Recruiting
First Posted : February 24, 2017
Last Update Posted : October 26, 2017
Universidade Federal do Rio de Janeiro
Rio de Janeiro State University
Information provided by (Responsible Party):
Ana Lúcia Vollú, Universidade Federal do Rio de Janeiro
The present study aims to evaluate, through a controlled clinical randomized study,the effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars when compared to atraumatic restorative treatment.
The present controlled clinical randomized study aiming at evaluating the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain or pulp involvement. The participants will be allocated randomly to one of two treatment groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In both groups, the guardians and children will receive oral hygiene instructions and will be advised about eating habits and fluoride dentifrice use.The clinical success will be verified through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical evaluations to detect caries arresting, representing the primary outcome of the study.
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Layout table for eligibility information
Ages Eligible for Study:
2 Years to 5 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
aged 2 to 5 years;
who are in good general health;
have at least one active dentin carious lesion on the occlusal surface of primary molars corresponding to ICDAS codes 5 or 6.
with systemic or neurological diseases;
whose families intend to move from Rio de Janeiro next year;
with a history of allergy to silver or any substance present in the different materials to be used for treatment.
with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement;
shows possible pulp involvement by radiographic examination