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Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

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ClinicalTrials.gov Identifier: NCT03063307
Recruitment Status : Recruiting
First Posted : February 24, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Rio de Janeiro State University
Information provided by (Responsible Party):
Ana Lúcia Vollú, 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.

Condition or disease Intervention/treatment Phase
Dental Caries in Children Procedure: Atraumatic Restorative Treatment Other: Silver Diamine Fluoride Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
Actual Study Start Date : September 20, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Active Comparator: Atraumatic Restorative Treatment Procedure: Atraumatic Restorative Treatment
Other Names:
  • ART
  • Glass Ionomer Cements
  • Ketac Molar Easymix

Experimental: Silver Diamine Fluoride Other: Silver Diamine Fluoride
Other Names:
  • SDF
  • SDF 30%
  • Cariostop 30% Biodinâmica




Primary Outcome Measures :
  1. Caries arresting [ Time Frame: 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 :
  1. Duration of the intervention visit [ Time Frame: 1 year ]
    Time (in minutes) spent on each type of intervention (DFP x ART)

  2. Cost [ Time Frame: 1 year ]
    The cost of each treatment will be recorded and compared to each other

  3. Aesthetic perception and treatment satisfaction [ Time Frame: First appointment, 3,6 and 12 months after treatment. ]
    Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.

  4. Anxiety [ Time Frame: 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.

  5. Quality of life assessment [ Time Frame: 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.



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063307


Contacts
Contact: Ana Lucia Vollu, MSD Student avollu@terra.com.br

Locations
Brazil
Departamento de Odontopediatria e Ortodontia da UFRJ Recruiting
Rio de Janeiro, Brazil, 21941-913
Contact: Ana Lucia Vollu, MSD Student       avollu@terra.com.br   
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State University
Investigators
Principal Investigator: Ana Lucia Vollu, MSD Student Universidade Federal Fluminense

Responsible Party: Ana Lúcia Vollú, Postgraduate student,, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT03063307     History of Changes
Other Study ID Numbers: silverdiamine
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ana Lúcia Vollú, Universidade Federal do Rio de Janeiro:
Tooth, Deciduous
Dental Caries
Glass Ionomer Cements
Dental Atraumatic Restorative Treatment
Cariostatic Agents
Fluorides

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs