Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

Universidade Federal do Rio de Janeiro119 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

119

Conditions

Dental Caries in Children

Interventions

Atraumatic Restorative TreatmentPROCEDURE

Silver Diamine FluorideOTHER

Eligibility

Sex: ALLMin age: 2 YearsMax age: 5 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Departamento de Odontopediatria e Ortodontia da UFRJ

Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

Caries arresting

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.

Time frame: The follow-up oral examinations will be conducted every 3 months for 48 months totally

Secondary Outcomes

Duration of the intervention visit

Time (in minutes) spent on each type of intervention (DFP x ART)

Time frame: 1 year

Cost

The cost of each treatment will be recorded and compared to each other

Time frame: 1 year

Aesthetic perception and treatment satisfaction

Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.

Time frame: First appointment, 3,6 and 12 months after treatment.

Anxiety

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.

Time frame: From allocation up to two weeks.

Quality of life assessment

Information about quality of life will be obtained through the questionnaire Brazilian Early Childhood Oral Health Impact Scale (B-ECOHIS), addressed to parents / guardians.

Time frame: First appointment,15 days and 3 months after treatment.

Data from ClinicalTrials.gov

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