Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

NCT ID: NCT03063307

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-20
• Study Completion Date: 2020-12-31

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 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.

Conditions

Dental Caries in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Atraumatic Restorative Treatment

Group Type: ACTIVE_COMPARATOR

Atraumatic Restorative Treatment

Intervention Type: PROCEDURE

Silver Diamine Fluoride

Group Type: EXPERIMENTAL

Silver Diamine Fluoride

Intervention Type: OTHER

Interventions

Atraumatic Restorative Treatment

Intervention Type: PROCEDURE

Silver Diamine Fluoride

Intervention Type: OTHER

Other Intervention Names

ART; Glass Ionomer Cements; Ketac Molar Easymix; SDF; SDF 30%; Cariostop 30% Biodinâmica

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role: lead

Responsible Party

Ana Lúcia Vollú

Postgraduate student,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana Lucia Vollu, MSD Student

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal Fluminense

Locations

Departamento de Odontopediatria e Ortodontia da UFRJ

Rio de Janeiro, , Brazil

Countries

Brazil

References

Rodrigues GF, Vollu AL, Vargas TR, Kamp LMK, da Cunha Costa T, Cruz LR, Luiz RR, Barja-Fidalgo F, Fonseca-Goncalves A. Efficacy of 30% silver diamine fluoride compared to atraumatic restorative treatment in arresting dentin caries lesions in preschoolers: a randomized clinical trial. Clin Oral Investig. 2024 Dec 6;29(1):3. doi: 10.1007/s00784-024-06081-8.

Reference Type: DERIVED

PMID: 39641816 (View on PubMed)

Other Identifiers

silverdiamine

Identifier Type: -

Identifier Source: org_study_id