NCT05395065

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
235

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 11, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

May 24, 2022

Last Update Submit

January 29, 2024

Conditions

Dental Caries in Children

Keywords

Silver Diamine FluorideSodium Fluoride VarnishDental CariesPrimary DentitionPeru

Outcome Measures

Primary Outcomes (2)

  • Lesion Activity

    Caries Lesion Arrest

    5 months

  • Lesion Activity

    Caries Lesion Arrest

    12 months

Secondary Outcomes (5)

  • Caries Increment

    5 months

  • Caries Increment

    12 months

  • New Caries Lesions

    5 months

  • New Caries Lesions

    12 months

  • Satisfaction with Color Changes in Teeth

    5 months

Study Arms (1)

SDF/FV

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

Device: Silver Diamine Fluoride/Sodium Fluoride Varnish

Interventions

Silver Diamine Fluoride/Sodium Fluoride VarnishDEVICE

Application of dental caries arresting topical medication

Also known as: Advantage Silver Dental Arrest 38% Gel, Fluorimax 2.5% Sodium Fluoride Varnish
SDF/FV

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The children will be recruited from five schools (Centro Educativo Inicial) in Puno, Peru

You may qualify if:

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

You may not qualify if:

  • Unable to cooperate with exam or procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

UGEL Manazo

Puno, Peru

Location

UGEL Puno 210001 Las Torres

Puno, Peru

Location

UGEL Puno Magisterial

Puno, Peru

Location

UGEL San Jose

Puno, Peru

Location

UGEL Villa del Lago

Puno, Peru

Location

Related Publications (3)

  • 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.

    PMID: 12407092BACKGROUND

  • 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.

    PMID: 35027545BACKGROUND

  • 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.

    PMID: 38678451DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Taina Padilla Caceres, DDS

    Universidad Nacional del Altiplano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

July 11, 2022

Primary Completion

July 17, 2023

Study Completion

January 29, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PE(5)