Nano Silver Fluoride vs. Silver Diamine Fluoride for Kids’ Cavities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a six-month, double-blind, parallel-group randomized trial conducted at ASDOH in Mesa, AZ. Children aged 6–10 with active caries on at least one primary molar and one permanent molar will receive Nano Silver Fluoride or Silver Diamine Fluoride to see which treatment better arrests caries and how accepted and safe each product is. The study compares cariostatic efficacy and also collects feedback from children, parents, and clinicians on aesthetics and usability. It is designed as a non-inferiority trial, focusing on whether NSF is not worse than SDF in arresting lesions while monitoring safety and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Are between the ages of 6 to 10 years.
* Are medically healthy.
* Have a minimum of one permanent deciduous molar tooth and one permanent first molar with an occlusal and/or proximal carious lesion classified as ICDAS II (International Caries Detection and Assessment System) Stage 3-4 (moderate caries) or Stage 5-6 (advanced caries).
* Must be able to understand and be willing to provide written child assent and parent/guardian consent for study participation.
* Must be willing and able to attend all study visits.
* Must be able to read and understand English and/or Spanish.
* Must be willing to provide feedback about study outcomes in their child (patient-reported/parent-reported outcome measures).

Exclusion Criteria

* Have a known sensitivity/allergy to fluoride, silver or other heavy-metal ions.
* Have a significant medical history, such as cardiac conditions that require antibiotic prophylaxis prior to dental treatment, or poorly controlled/uncontrolled diabetes.
* Present with ulcerative gingivitis or aphthous stomatitis.
* Have a history of full mouth gingivectomy.
* Chronically take medications that reduce salivary flow, including stimulants for ADHD and antihistamines for seasonal allergies.
* Have a history of systemic disease that reduces salivary flow, such as an autoimmune disease.
* Deciduous molars are loose at the initial screening examination visit.
* Deciduous molars or first permanent molars with occlusal and/or proximal caries have an existing restoration or recurrent caries at the site of potential study treatment.
* Deciduous molars or first permanent molars have extensive occlusal and/or proximal caries with pulpal involvement and/or require surgical intervention for treatment.

Where it's running

• Arizona School of Dentistry & Oral Health (ASDOH), A.T. Still University
  Mesa, Arizona, United States Recruiting

Study contacts

• Study coordinator: Marc Shlossman Associate Director of Clinical Research, DDS, MS
• Email: mshlossman@atsu.edu
• Phone: (480) 248-8151

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.