Silver Diamine Fluoride Gel: Single Group Observational Study (KiruPoderoso)

Evaluation of the Response of Caries Lesions in Dentin After Application of Silver Diamine Fluoride Gel and Sodium Fluoride Varnish: A Single Group Observational Study

A single group observational study 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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Device: Silver Diamine Fluoride/Sodium Fluoride Varnish

Detailed Description

A single group observational study 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.

• Study Type: Observational
• Enrollment (Actual): 237

Contacts and Locations

Study Locations

• Peru
  • Puno
    • Puno, Puno, Peru
      • UGEL Manazo
    • Puno, Puno, Peru
      • UGEL Puno 210001 Las Torres
    • Puno, Puno, Peru
      • UGEL Puno Magisterial
    • Puno, Puno, Peru
      • UGEL San Jose
    • Puno, Puno, Peru
      • UGEL Villa del Lago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to cooperate with exam or procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Application of dental caries arresting topical medication; Other Names: Advantage Silver Dental Arrest 38% Gel; Fluorimax 2.5% Sodium Fluoride Varnish

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Activity	Percentage of baseline d2/d3 caries lesions arrested at 12-month follow-up. The outcome measured on each participant is the percentage of baseline d2/d3 caries lesions arrested at 12-month follow-up. It is not a binary outcome measured at the participant level. To summarize the outcome the median value based on participants with 12 month follow-up is reported, along with the interquartile range (25th and 75th percentile) and 95% confidence interval. For surfaces scored from d1 through d4, the lesion was classi ed as active or inactive using an adaptation of criteria developed by Nyvad and colleagues (Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999;33(4):252-260).	12 months
Lesion Activity	Percentage of baseline d2/d3 caries lesions arrested at 5-month follow-up. The outcome measured on each participant is the percentage of baseline d2/d3 caries lesions arrested at 5-month follow-up. It is not a binary outcome measured at the participant level. To summarize the outcome the median value based on participants with 5 month follow-up is reported, along with the interquartile range (25th and 75th percentile) and 95% confidence interval. For surfaces scored from d1 through d4, the lesion was classi ed as active or inactive using an adaptation of criteria developed by Nyvad and colleagues (Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999;33(4):252-260).	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries Increment	Number of new caries (d2-4mfs) from baseline to 5-month follow-up.	5 months
Caries Increment	Number of new caries (d2-4mfs) from baseline to 12-month follow-up.	12 months
Incidence of (New) Caries Lesions	The incidence of (new) caries lesions (d2-4mfs) per 1 surface-year at risk is the number of new caries lesions at 5 month divided by the surface time at risk between baseline and 5 months. The incidence is calculated for each participant and then summarized by the median, interquartile range (25th and 75th percentiles) and 95% confidence interval. The incidence rate is expressed as the number of new caries lesions per 1 surface-year at risk.	5 months
Incidence of (New) Caries Lesions	The incidence of (new) caries lesions (d2-4mfs) per 1 surface-year at risk is the number of new caries lesions at 12 months divided by the surface time at risk between baseline and 5 months. The incidence is calculated for each participant and then summarized by the median, interquartile range (25th and 75th percentiles) and 95% confidence interval. The incidence rate is expressed as the number of new caries lesions per 1 surface-year at risk.	12 months
Satisfaction With Color Changes in Teeth	Bothered by color changes in the teeth (1-10 scale), where 1 = not at all bothered and 10 = very bothered. Higher scores mean more bothered.	12 months

Collaborators and Investigators

• Sponsor: Advantage Silver Dental Arrest, LLC
• Collaborators: University of Washington; Universidad Nacional Del Altiplano Puno
• Investigators: Principal Investigator: Taina Padilla Caceres, DDS, Universidad Nacional del Altiplano

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): January 29, 2024

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 17, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Dental Caries; Silver Diamine Fluoride; Peru; Sodium Fluoride Varnish; Primary Dentition
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride; Fluorides, Topical
• Other Study ID Numbers: Gel 2022-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes