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Completed

NCT Number: NCT05395065

Silver Diamine Fluoride Gel: 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.

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Key information

Conditions

Dental Caries in Children Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UGEL Manazo, Puno, Peru

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unable to cooperate with exam or procedure

Treatment and study plan

Silver Diamine Fluoride/Sodium Fluoride Varnish

Device

Application of dental caries arresting topical medication

Other names: Advantage Silver Dental Arrest 38% Gel, Fluorimax 2.5% Sodium Fluoride Varnish

Primary outcomes

  1. Lesion Activity

    Time frame: 12 months

    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).

  2. Lesion Activity

    Time frame: 5 months

    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).

Secondary outcomes

  1. Caries Increment

    Time frame: 5 months

    Number of new caries (d2-4mfs) from baseline to 5-month follow-up.

  2. Caries Increment

    Time frame: 12 months

    Number of new caries (d2-4mfs) from baseline to 12-month follow-up.

  3. Incidence of (New) Caries Lesions

    Time frame: 5 months

    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.

  4. Incidence of (New) Caries Lesions

    Time frame: 12 months

    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.

  5. Satisfaction With Color Changes in Teeth

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Advantage Silver Dental Arrest, LLC

Industry

Collaborators

  • Universidad Nacional Del Altiplano Puno
  • University of Washington

Registry information

Official study title

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

Acronym: KiruPoderoso

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 27, 2022
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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