Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
1 other identifier
interventional
119
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 20, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 4, 2021
March 1, 2021
2.3 years
February 15, 2017
March 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Duration of the intervention visit
1 year
Cost
1 year
Aesthetic perception and treatment satisfaction
First appointment, 3,6 and 12 months after treatment.
Anxiety
From allocation up to two weeks.
Quality of life assessment
First appointment,15 days and 3 months after treatment.
Study Arms (2)
Atraumatic Restorative Treatment
ACTIVE COMPARATORSilver Diamine Fluoride
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Departamento de Odontopediatria e Ortodontia da UFRJ
Rio de Janeiro, 21941-913, Brazil
Related Publications (1)
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.
PMID: 39641816DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Lucia Vollu, MSD Student
Universidade Federal Fluminense
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postgraduate student,
Study Record Dates
First Submitted
February 15, 2017
First Posted
February 24, 2017
Study Start
September 20, 2016
Primary Completion
December 31, 2018
Study Completion
December 31, 2020
Last Updated
March 4, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share