Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
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|ClinicalTrials.gov Identifier: NCT03063307|
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries in Children||Procedure: Atraumatic Restorative Treatment Other: Silver Diamine Fluoride||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial|
|Actual Study Start Date :||September 20, 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||May 31, 2020|
|Active Comparator: Atraumatic Restorative Treatment||
Procedure: Atraumatic Restorative Treatment
|Experimental: Silver Diamine Fluoride||
Other: Silver Diamine Fluoride
- Caries arresting [ 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.
- Duration of the intervention visit [ Time Frame: 1 year ]Time (in minutes) spent on each type of intervention (DFP x ART)
- Cost [ Time Frame: 1 year ]The cost of each treatment will be recorded and compared to each other
- Aesthetic perception and treatment satisfaction [ 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.
- Anxiety [ 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.
- Quality of life assessment [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063307
|Contact: Ana Lucia Vollu, MSD Studentfirstname.lastname@example.org|
|Departamento de Odontopediatria e Ortodontia da UFRJ||Recruiting|
|Rio de Janeiro, Brazil, 21941-913|
|Contact: Ana Lucia Vollu, MSD Student email@example.com|
|Principal Investigator:||Ana Lucia Vollu, MSD Student||Universidade Federal Fluminense|