Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 1216 for:    tooth decay

Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE February 15, 2017
First Posted Date  ICMJE February 24, 2017
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE September 20, 2016
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03063307 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
  • Duration of the intervention visit [ Time Frame: 1 year ]
    Time (in minutes) spent on each type of intervention (DFP x ART)
  • Cost [ Time Frame: 1 year ]
    The cost of each treatment will be recorded and compared to each other
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2017)
  • 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.
  • 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.
  • Quality of life assessment [ Time Frame: First appointment,15 days ,3,6 and 12 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
Official Title  ICMJE Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries in Children
Intervention  ICMJE
  • Procedure: Atraumatic Restorative Treatment
    Other Names:
    • ART
    • Glass Ionomer Cements
    • Ketac Molar Easymix
  • Other: Silver Diamine Fluoride
    Other Names:
    • SDF
    • SDF 30%
    • Cariostop 30% Biodinâmica
Study Arms  ICMJE
  • Active Comparator: Atraumatic Restorative Treatment
    Intervention: Procedure: Atraumatic Restorative Treatment
  • Experimental: Silver Diamine Fluoride
    Intervention: Other: Silver Diamine Fluoride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 20, 2017)
118
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2020
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ana Lucia Vollu, MSD Student avollu@terra.com.br
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03063307
Other Study ID Numbers  ICMJE silverdiamine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ana Lúcia Vollú, Universidade Federal do Rio de Janeiro
Study Sponsor  ICMJE Universidade Federal do Rio de Janeiro
Collaborators  ICMJE Rio de Janeiro State University
Investigators  ICMJE
Principal Investigator: Ana Lucia Vollu, MSD Student Universidade Federal Fluminense
PRS Account Universidade Federal do Rio de Janeiro
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP