AzTrials
AzTrials

Dental Caries in ChildrenKiruPoderosoNCT05395065

Silver Diamine Fluoride Gel: Single Group Observational Study

An observational study of Dental Caries in Children, run by Advantage Silver Dental Arrest, LLC at 5 sites in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 3 to 4 years
Conditions the study is for
Dental Caries in Children
What is being tested?
Silver Diamine Fluoride/Sodium Fluoride Varnish
Type of treatment
Medical device
How many people
237 participants
Where
5 sitesPeru
Study dates
11 Jul 2022to 29 Jan 2024
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 4 years
  • All sexes
  • Child

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

Who may be able to join

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

Who cannot join

  • Unable to cooperate with exam or procedure

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Peru5 sites

  • UGEL Manazo

    Puno, Puno

  • UGEL Puno 210001 Las Torres

    Puno, Puno

  • UGEL Puno Magisterial

    Puno, Puno

  • UGEL San Jose

    Puno, Puno

  • UGEL Villa del Lago

    Puno, Puno

Other trials in Peru

About this study

Official 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

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.

Read the 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.

Being tested
Silver Diamine Fluoride/Sodium Fluoride Varnish
Keywords
Silver Diamine Fluoride, Sodium Fluoride Varnish, Dental Caries, Primary Dentition, Peru
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Silver Diamine Fluoride/Sodium Fluoride VarnishDevice

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

    Application of dental caries arresting topical medication

Study groups in NCT05395065
Study groupRoleWhat they receive
SDF/FVTopical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months
Receives: Device: Silver Diamine Fluoride/Sodium Fluoride Varnish

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 12 months

  2. 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).

    Measured: 5 months

Secondary outcomes (5)

  1. Caries Increment

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

    Measured: 5 months

  2. Caries Increment

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

    Measured: 12 months

  3. 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.

    Measured: 5 months

  4. 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.

    Measured: 12 months

  5. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start11 Jul 2022
  3. Primary completion17 Jul 2023
  4. Study completion29 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
237 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395065
Sponsor's protocol ID
Gel 2022-1
Acronym
KiruPoderoso
Status last verified
Jun 2026
First submitted
24 May 2022
Last updated
17 Aug 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 12407092

  • 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.

    PubMed 35027545

  • 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.

    PubMed 38678451

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Caries in Children, run by Advantage Silver Dental Arrest, LLC at 5 sites in Peru.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lesion Activity (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05395065, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in