Departamento de Odontopediatria e Ortodontia da UFRJ
Rio de Janeiro, 21941-913, Brazil
NCT Number: NCT03063307
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.
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Notify Me2 year–5 year
All sexes
Interventional
Not applicable
Rio de Janeiro, 21941-913, Brazil
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TEETH
Other names: ART, Glass Ionomer Cements, Ketac Molar Easymix
Other names: SDF, SDF 30%, Cariostop 30% Biodinâmica
Time frame: The follow-up oral examinations will be conducted every 3 months for 48 months totally
The main outcome of the study will be the observation of the proportion of arrested caries lesions in the test group, compared to the control group.
Time frame: 1 year
Time (in minutes) spent on each type of intervention (DFP x ART)
Time frame: 1 year
The cost of each treatment will be recorded and compared to each other
Time frame: First appointment, 3,6 and 12 months after treatment.
Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.
Time frame: From allocation up to two weeks.
A facial imaging scale will be used to assess the degree of anxiety of children 3 years of age or older. before and after first exam and treatment appointments.
Time frame: First appointment,15 days and 3 months after treatment.
Information about quality of life will be obtained through the questionnaire Brazilian Early Childhood Oral Health Impact Scale (B-ECOHIS), addressed to parents / guardians.
Universidade Federal do Rio de Janeiro
Other
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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