Clinical Trial: Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Universidade Federal do Rio de Janeiro

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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:

  • 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.


Information By: Universidade Federal do Rio de Janeiro

Dates:
Date Received: February 15, 2017
Date Started: September 20, 2016
Date Completion: May 31, 2020
Last Updated: May 16, 2017
Last Verified: May 2017