A.T. Still University of Health Sciences
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.
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 Spani…
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.