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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05395065
Other study ID # Gel 2022-1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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