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.
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.
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.
Parallel
Nano Silver Fluoride / NSF
DrugThe 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.
Change in the Carious Lesion Status after Treatment
Carious teeth will be determined using ICDAS II criteria, Stage 3-4 (moderate stage caries) or Stage 5-6 (advanced stage caries) on the occlusal and/or proximal surface(s). The carious lesion is deemed "active" if there is a greater likelihood of progression into the deeper layers of tooth structure. After treatment with the randomly assigned study intervention, using a ball-tip probe, a carious lesion will be scored as active, if the lesion feels soft or leathery on gently probing the dentin. The carious lesion will be scored as arrested if the lesion feels hard on gently probing the dentin. The initial examiner who applies the intervention will be blinded to the study product and will record their score(s) for each treated lesion. A second examiner will be blinded to the study product and to the score(s) recorded by the initial examiner; they will record their score(s) separately.
Change in Tooth Color/Shade from Baseline to Post-Treatment
VITA Easyshade® V uses spectrophotometry in the 400-700 nm range to objectively measure the light reflectance of natural teeth, ceramic restorations, and bleached teeth It is designed for fast, reliable, and reproducible shade matching, eliminating the subjectivity of traditional visual shade guides. There is a standardized set of 16 natural, empirically induced tooth shades that allow dentists and dental laboratories to match restorations to natural tooth color with high accuracy. How the system works: * A, B, C, D = the lettering represents hue groups (color tone) * 1-4 = the numbering represents value steps or gradients from lightest to darkest; 1 represents the lightest color, while 4 represents the darkest color * A1-A4: reddish brownish tones * B1-B4: reddish yellowish tones * C1-C4: greyish tones * D2-D4: reddish grey tones
Early Childhood Oral Health Impact Scale (ECOHIS)
The validated ECOHIS will be used to assess the impact of oral health problems and related treatment experiences on the quality of life of study participants and their families. The scale consists of six subscales: Child Symptom Domain, Child Function Domain, Child Psychological Domain, Child Self-Image/social Interaction Domain, Parent Distress Domain, and Family Function Domain. The ECOHIS consists of 13 items that are scored using a 6 point Likert scale: Response options: 1. Never, 2. Hardly ever, 3. Occasionally, 4. Often, 5. Very often, and 6. Don't know. Parents/guardians will be guided to complete the ECOHIS using the following instructions: "Problems with the teeth, mouth or jaws and their treatment can affect the well-being and everyday lives of children and their families. For each of the following questions, please circle the number next to the response that best describes your child's experiences or your own. Consider the child's entire life from birth until now.
Status of Child Behavior During Treatment
The child subject's behavior during study product application will be documented as either cooperative or uncooperative (dichotomous). Lack of cooperation could affect optimal product placement.
Status of Child Satisfaction with Appearance of Treated Teeth (Patient Reported Outcome Measure)
Child subjects' satisfaction with the appearance of their teeth that have had the study treatment will be captured by asking the child to select a picture that depicts choices using a 3-item Likert Scale: Happy (smiley face), Unsure (thinking face with a question mark above it), or Sad (frowning face). A score will be assigned to each choice: Happy (3), Unsure (2), Sad (1).
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