Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
- Conditions
- Dental Caries in Children
- Interventions
- Procedure: Atraumatic Restorative TreatmentOther: Silver Diamine Fluoride
- Registration Number
- NCT03063307
- Lead Sponsor
- Universidade Federal do Rio de Janeiro
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
-
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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Atraumatic Restorative Treatment Atraumatic Restorative Treatment - Silver Diamine Fluoride Silver Diamine Fluoride -
- Primary Outcome Measures
Name Time Method Caries arresting 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.
- Secondary Outcome Measures
Name Time Method Cost 1 year The cost of each treatment will be recorded and compared to each other
Aesthetic perception and treatment satisfaction First appointment, 3,6 and 12 months after treatment. Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.
Duration of the intervention visit 1 year Time (in minutes) spent on each type of intervention (DFP x ART)
Quality of life assessment 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.
Anxiety 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.
Trial Locations
- Locations (1)
Departamento de Odontopediatria e Ortodontia da UFRJ
🇧🇷Rio de Janeiro, Brazil