Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries

Dental Caries in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03063307
• Other study ID #: silverdiamine
• Status: Completed
• Phase: N/A
• Start date: September 20, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Procedure:
• Atraumatic Restorative Treatment

Other:
• Silver Diamine Fluoride

Locations

Country	Name	City	State
Brazil	Departamento de Odontopediatria e Ortodontia da UFRJ	Rio de Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of the intervention visit	Time (in minutes) spent on each type of intervention (DFP x ART)	1 year
Secondary	Cost	The cost of each treatment will be recorded and compared to each other	1 year
Secondary	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.
Secondary	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.
Secondary	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.