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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03063307
Other study ID # silverdiamine
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2016
Est. completion date December 31, 2020

Study information

Verified date March 2021
Source Universidade Federal do Rio de Janeiro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Atraumatic Restorative Treatment

Other:
Silver Diamine Fluoride


Locations

Country Name City State
Brazil Departamento de Odontopediatria e Ortodontia da UFRJ Rio de Janeiro

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal do Rio de Janeiro Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

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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