Dental Caries in Children Clinical Trial
Official title:
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
Verified date | March 2021 |
Source | Universidade Federal do Rio de Janeiro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 119 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 5 Years |
Eligibility | Inclusion Criteria: - CHILDREN - 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. Exclusion Criteria: - CHILDREN - 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. TEETH - with spontaneous or provoked pain, dental mobility or radiographic signs of involvement or possible pulp involvement; - shows possible pulp involvement by radiographic examination |
Country | Name | City | State |
---|---|---|---|
Brazil | Departamento de Odontopediatria e Ortodontia da UFRJ | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Rio de Janeiro | Rio de Janeiro State University |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caries arresting | 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. | The follow-up oral examinations will be conducted every 3 months for 48 months totally | |
Secondary | Duration of the intervention visit | Time (in minutes) spent on each type of intervention (DFP x ART) | 1 year | |
Secondary | Cost | The cost of each treatment will be recorded and compared to each other | 1 year | |
Secondary | Aesthetic perception and treatment satisfaction | Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians. | First appointment, 3,6 and 12 months after treatment. | |
Secondary | Anxiety | 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. | From allocation up to two weeks. | |
Secondary | Quality of life assessment | Information about quality of life will be obtained through the questionnaire Brazilian Early Childhood Oral Health Impact Scale (B-ECOHIS), addressed to parents / guardians. | First appointment,15 days and 3 months after treatment. |
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