Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
Primary Purpose
Dental Caries in Children
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Atraumatic Restorative Treatment
Silver Diamine Fluoride
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries in Children focused on measuring Tooth, Deciduous, Dental Caries, Glass Ionomer Cements, Dental Atraumatic Restorative Treatment, Cariostatic Agents, Fluorides
Eligibility Criteria
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
Sites / Locations
- Departamento de Odontopediatria e Ortodontia da UFRJ
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Atraumatic Restorative Treatment
Silver Diamine Fluoride
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Duration of the intervention visit
Time (in minutes) spent on each type of intervention (DFP x ART)
Cost
The cost of each treatment will be recorded and compared to each other
Aesthetic perception and treatment satisfaction
Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.
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.
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.
Full Information
NCT ID
NCT03063307
First Posted
February 15, 2017
Last Updated
March 2, 2021
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State University
1. Study Identification
Unique Protocol Identification Number
NCT03063307
Brief Title
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
Official Title
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Rio de Janeiro State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Tooth, Deciduous, Dental Caries, Glass Ionomer Cements, Dental Atraumatic Restorative Treatment, Cariostatic Agents, Fluorides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atraumatic Restorative Treatment
Arm Type
Active Comparator
Arm Title
Silver Diamine Fluoride
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Atraumatic Restorative Treatment
Other Intervention Name(s)
ART, Glass Ionomer Cements, Ketac Molar Easymix
Intervention Type
Other
Intervention Name(s)
Silver Diamine Fluoride
Other Intervention Name(s)
SDF, SDF 30%, Cariostop 30% Biodinâmica
Primary Outcome Measure Information:
Title
Caries arresting
Description
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.
Time Frame
The follow-up oral examinations will be conducted every 3 months for 48 months totally
Secondary Outcome Measure Information:
Title
Duration of the intervention visit
Description
Time (in minutes) spent on each type of intervention (DFP x ART)
Time Frame
1 year
Title
Cost
Description
The cost of each treatment will be recorded and compared to each other
Time Frame
1 year
Title
Aesthetic perception and treatment satisfaction
Description
Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.
Time Frame
First appointment, 3,6 and 12 months after treatment.
Title
Anxiety
Description
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.
Time Frame
From allocation up to two weeks.
Title
Quality of life assessment
Description
Information about quality of life will be obtained through the questionnaire Brazilian Early Childhood Oral Health Impact Scale (B-ECOHIS), addressed to parents / guardians.
Time Frame
First appointment,15 days and 3 months after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Lucia Vollu, MSD Student
Organizational Affiliation
Universidade Federal Fluminense
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Odontopediatria e Ortodontia da UFRJ
City
Rio de Janeiro
ZIP/Postal Code
21941-913
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
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