Recruiting

NSF vs. SDF

Sponsor:

A.T. Still University of Health Sciences

Code:

NCT07861321

Conditions

Dental Caries

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

Interventions

Nano Silver Fluoride / NSF

Study Details

Brief summary:

This study, titled "A Randomized Controlled Trial to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children" (Study Number: ATSU-YI-NSF 2025), is sponsored by Young Innovations and conducted at the Arizona School of Dentistry \& Oral Health (ASDOH) at A.T. Still University in Mesa, Arizona, under Principal Investigator Marc Shlossman, DDS, MS. The primary objective is to validate and compare the cariostatic efficacy of Nano Silver Fluoride (ClearDefense®) against Silver Diamine Fluoride (AdvantageArrest®) in pediatric dental patients with active carious lesions on primary molars and first permanent molars. Designed as a non-inferiority trial, it evaluates whether Nano Silver Fluoride provides comparable caries-arresting effects while assessing patient, parent, and provider acceptance, tooth color changes, and overall product safety. The trial is structured as a six-month, double-blind, parallel-group, single-site randomized controlled study with an optional twelve-month follow-up visit. To achieve a target sample size of 60 evaluable subjects (30 per treatment group) while accounting for a projected 20% dropout rate, a total of 72 pediatric participants will be recruited. Subjects are randomly assigned to treatment arms using an online random number generator. Allocation concealment and double-blinding are maintained by a third-party study coordinator who prepares treatment supplies on preset trays, keeping trial investigators, outcome examiners, and participants masked to product identity. Eligible participants include medically healthy children aged 6 to 10 years who present with at least one primary molar or permanent first molar containing active occlusal or proximal caries classified as ICDAS II Stage 3 through 6. Children and their parents or guardians must read and understand English or Spanish, provide written assent and consent, and agree to attend all required study visits. Exclusion criteria apply to children with known allergies to fluoride or silver, significant systemic conditions, ulcerative oral lesions, or conditions reducing salivary flow, as well as target teeth with loose roots, pulpal involvement, or existing restorations. At the baseline visit, active carious lesions receive a single topical application of either ClearDefense® (3% sodium fluoride + 0.2% silver ion) or AdvantageArrest® (38% silver diamine fluoride) for at least one minute. Mandatory study appointments occur at baseline, 3 months, 6 months, and an optional 12 months, incorporating clinical oral examinations, tooth cleaning, radiographs, intraoral photographs, and digital tooth shade assessments using a Vita Easyshade V spectrophotometer. The primary response variable is the clinical status of the carious lesion (active vs. arrested) measured at 3 and 6 months. Secondary outcome measures include pre- and post-treatment tooth color changes, parent-reported quality of life via the Early Childhood Oral Health Impact Scale (ECOHIS), child satisfaction regarding taste (using the TASTY scale at baseline) and tooth appearance, parent treatment acceptability, investigator ease-of-use feedback at study closeout, and documentation of adverse events including soft tissue staining or localized pain.

Conditions

Dental Caries

Study ID

NCT07861321

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2030

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Experimental Arm (Nano Silver Fluoride / NSF)

Participants receive a single topical application of ClearDefense® (3% sodium fluoride + 0.2% silver ion) to active carious lesions

active comparator: Active Comparator Arm (Silver Diamine Fluoride / SDF)

Participants receive a single topical application of AdvantageArrest® (38% silver diamine fluoride) to active carious lesions

Interventions

Nano Silver Fluoride / NSF

The intervention consists of a single topical application of either ClearDefense® Nano Silver Fluoride (3% sodium fluoride + 0.2% silver ion) or AdvantageArrest® Silver Diamine Fluoride (38% SDF) directly onto active carious lesions on primary molars or first permanent molars. Prior to treatment, visible plaque is removed using a tapered brush prophy angle, baseline tooth shade is recorded, and the target teeth are isolated with cotton rolls and gauze before being dried with an air-water syringe. To maintain blinding, a study coordinator dispenses two drops of the assigned agent into a dappen dish, and the study investigator applies the product across the entire carious lesion using a microbrush, allowing it to sit for at least one minute while soft tissues are retracted to avoid staining. Finally, excess product is wiped away with gauze or a cotton roll, and participants are instructed to refrain from eating or drinking for at least 30 minutes post-application.

Primary outcome measure

  • Change in the Carious Lesion Status after Treatment [ Time Frame: Change in carious lesion status post-treatment from Baseline to 3 months, and 3 months to 6 months. There is an optional assessment for volunteers to return to assess change in carious lesion status from 6 months to 12 months. ]

Central Contacts and Locations

Central contacts

Marc Shlossman Associate Director of Clinical Research, DDS, MS

(480) 248-8151mshlossman@atsu.edu

Ann Eshenaur Spolarich Professor and Assistant Dean for Research, RDH, PhD

(480) 248-8153ASpolarich@atsu.edu

Locations

Arizona School of Dentistry & Oral Health (ASDOH), A.T. Still University

Recruiting

Mesa, Arizona, United States, 85206

Contacts

Marc Shlossman, DDS, MS

480-248-8153mshlossman@atsu.edu

More Information

Sponsor

A.T. Still University of Health Sciences

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by A.T. Still University of Health Sciences on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.