Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Procedure: Atraumatic Restorative Treatment; Other: Silver Diamine Fluoride

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: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21941-913
    • Departamento de Odontopediatria e Ortodontia da UFRJ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Atraumatic Restorative Treatment	Procedure: Atraumatic Restorative Treatment; Other Names: ART; Glass Ionomer Cements; Ketac Molar Easymix
EXPERIMENTAL: Silver Diamine Fluoride	Other: Silver Diamine Fluoride; Other Names: SDF; SDF 30%; Cariostop 30% Biodinâmica

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The follow-up oral examinations will be conducted every 3 months for 48 months totally

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the intervention visit	Time (in minutes) spent on each type of intervention (DFP x ART)	1 year
Cost	The cost of each treatment will be recorded and compared to each other	1 year
Aesthetic perception and treatment satisfaction	Information on aesthetic perception will be obtained through a questionnaire, addressed to parents / guardians.	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.	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.	First appointment,15 days and 3 months after treatment.

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: Rio de Janeiro State University
• Investigators: Principal Investigator: Ana Lucia Vollu, MSD Student, Universidade Federal Fluminense

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 20, 2016
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2020

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Dental Caries; Dental Atraumatic Restorative Treatment; Fluorides; Cariostatic Agents; Glass Ionomer Cements; Tooth, Deciduous
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: silverdiamine

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO