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Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

U

Universidade Federal do Rio de Janeiro

Status

Completed

Conditions

Dental Caries in Children

Treatments

Procedure: Atraumatic Restorative Treatment
Other: Silver Diamine Fluoride

Study type

Interventional

Funder types

Other

Identifiers

NCT03063307
silverdiamine

Details and patient eligibility

About

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.

Full 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.

Enrollment

119 patients

Sex

All

Ages

2 to 5 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

119 participants in 2 patient groups

Atraumatic Restorative Treatment
Active Comparator group
Treatment:
Procedure: Atraumatic Restorative Treatment
Silver Diamine Fluoride
Experimental group
Treatment:
Other: Silver Diamine Fluoride

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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