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Completed

NCT Number: NCT03063307

Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

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.

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departamento de Odontopediatria e Ortodontia da UFRJ

Rio de Janeiro, 21941-913, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atraumatic Restorative Treatment

Procedure

Other names: ART, Glass Ionomer Cements, Ketac Molar Easymix

Silver diamine fluoride

Other

Other names: SDF, SDF 30%, Cariostop 30% Biodinâmica

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Rio de Janeiro State University

Registry information

Official study title

Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries in Deciduous Molars: a Controlled and Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Feb 24, 2017
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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