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| Name | Class |
|---|---|
| Rio de Janeiro State University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atraumatic Restorative Treatment | Active Comparator |
| |
| Silver Diamine Fluoride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atraumatic Restorative Treatment | Procedure |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the intervention visit | Time (in minutes) spent on each type of intervention (DFP x ART) | 1 year |
| Cost | The cost of each treatment will be recorded and compared to each other |
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Inclusion Criteria:
CHILDREN
Exclusion Criteria:
CHILDREN
TEETH
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| Name | Affiliation | Role |
|---|---|---|
| Ana Lucia Vollu, MSD Student | Universidade Federal Fluminense | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Odontopediatria e Ortodontia da UFRJ | Rio de Janeiro | 21941-913 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39641816 | Derived | Rodrigues GF, Vollu AL, Vargas TR, Kamp LMK, da Cunha Costa T, Cruz LR, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment in arresting dentin caries lesions in preschoolers: a randomized clinical trial. Clin Oral Investig. 2024 Dec 6;29(1):3. doi: 10.1007/s00784-024-06081-8. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D057087 | Dental Atraumatic Restorative Treatment |
| D005899 | Glass Ionomer Cements |
| C515713 | Ketac Molar Easymix |
| C024633 | silver diamine fluoride |
| ID | Term |
|---|---|
| D003813 | Dentistry |
| D003738 | Dental Cements |
| D003764 | Dental Materials |
| D001697 | Biomedical and Dental Materials |
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| Silver Diamine Fluoride | Other |
|
|
| 1 year |
| 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. |
| 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. |
| 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. |
| D008420 |
| Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |