Silver Diamine Fluoride Gel: Case Series

Dental Caries in Children Clinical Trial

— KiruPoderoso  

Official title:

Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel: A Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05395065
• Other study ID #: Gel 2022-1
• Status: Completed
• Start date: July 11, 2022
• Est. completion date: January 29, 2024

Study information

• Verified date: January 2024
• Source: Advantage Silver Dental Arrest, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

Description:

A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: January 29, 2024
• Est. primary completion date: July 17, 2023
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

Inclusion Criteria:

• At least one active caries lesion Good general health by parent report

Exclusion Criteria:

• Unable to cooperate with exam or procedure

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Device:
• Silver Diamine Fluoride/Sodium Fluoride Varnish
Application of dental caries arresting topical medication

Locations

Country	Name	City	State
Peru	UGEL Manazo	Puno
Peru	UGEL Puno 210001 Las Torres	Puno
Peru	UGEL Puno Magisterial	Puno
Peru	UGEL San Jose	Puno
Peru	UGEL Villa del Lago	Puno

Sponsors (3)

Lead Sponsor	Collaborator
Advantage Silver Dental Arrest, LLC	Universidad Nacional Del Altiplano Puno, University of Washington

Country where clinical trial is conducted

Peru, 

References & Publications (2)

Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767. — View Citation

Kiesow A, Menzel M, Lippert F, Tanzer JM, Milgrom P. Dentin tubule occlusion by a 38% silver diamine fluoride gel: an in vitro investigation. BDJ Open. 2022 Jan 13;8(1):1. doi: 10.1038/s41405-022-00095-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion Activity	Caries Lesion Arrest	5 months
Primary	Lesion Activity	Caries Lesion Arrest	12 months
Secondary	Caries Increment	Caries Increment (d2-4mfs)	5 months
Secondary	Caries Increment	Caries Increment (d2-4mfs)	12 months
Secondary	New Caries Lesions	Rate of New Caries Lesions ((d2-4mfs)	5 months
Secondary	New Caries Lesions	Rate of New Caries Lesions ((d2-4mfs)	12 months
Secondary	Satisfaction with Color Changes in Teeth	Bothered by Color Changes in the teeth (1-10 scale)	5 months