Silver Diamine Fluoride Gel: Case Series

NCT ID: NCT05395065

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

235 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-11

Study Completion Date

2024-01-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Caries in Children

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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SDF/FV

Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months

Silver Diamine Fluoride/Sodium Fluoride Varnish

Intervention Type DEVICE

Application of dental caries arresting topical medication

Interventions

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Silver Diamine Fluoride/Sodium Fluoride Varnish

Application of dental caries arresting topical medication

Intervention Type DEVICE

Other Intervention Names

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Advantage Silver Dental Arrest 38% Gel Fluorimax 2.5% Sodium Fluoride Varnish

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unable to cooperate with exam or procedure
Minimum Eligible Age

3 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Nacional Del Altiplano Puno

UNKNOWN

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Advantage Silver Dental Arrest, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taina Padilla Caceres, DDS

Role: PRINCIPAL_INVESTIGATOR

Universidad Nacional del Altiplano

Locations

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UGEL Manazo

Puno, , Peru

Site Status

UGEL Puno 210001 Las Torres

Puno, , Peru

Site Status

UGEL Puno Magisterial

Puno, , Peru

Site Status

UGEL San Jose

Puno, , Peru

Site Status

UGEL Villa del Lago

Puno, , Peru

Site Status

Countries

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Peru

References

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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.

Reference Type BACKGROUND
PMID: 12407092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35027545 (View on PubMed)

Padilla Caceres TC, Cervantes-Alagon S, Castillo JL, Vera Reyes CM, Rothen M, Mancl LA, Milgrom P. Using sequential applications of a novel silver diamine fluoride gel and sodium fluoride varnish to arrest severe early childhood caries lesions: A clinical trial with single group assignment. J Am Dent Assoc. 2024 Jun;155(6):526-535. doi: 10.1016/j.adaj.2024.02.013. Epub 2024 Apr 25.

Reference Type DERIVED
PMID: 38678451 (View on PubMed)

Other Identifiers

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Gel 2022-1

Identifier Type: -

Identifier Source: org_study_id

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