A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children

• Nano Silver Fluoride / NSF (Device): 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 outcomes

• Change in the Carious Lesion Status after Treatment [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.]: 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.

Secondary outcomes

• Change in Tooth Color/Shade from Baseline to Post-Treatment [Tooth color/shade will be measured at Baseline pre- and post-teatment; then comparing post-treatment to color/shade at 3 months and at 6 months. There is an option for volunteers to return to assess tooth color/shade from post-treatment at 12 months]: 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) [Changes in ECOHIS will be compared from Baseline to 6 months, with an optional 12 month visit when ECOHIS scores will be compared to both Baseline and 6 months.]: 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 status of the child's behavior is recorded post-treatment at the initial (Baseline) visit only.]: 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 satisfaction with the appearance of their teeth will be recorded immediately post-treatment at Baseline, then compared to Baseline at 3 months and 6 months. There will be an optional 12 month score to compare against the Baseline score.]: 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).
• Status of Child Satisfaction with Product Taste (Patient Reported Outcome Measure) [The child's TASTY score will be recorded immediately post-treatment at the initial (Baseline) visit only.]: The child will be asked to use the validated TASTY scale to assess their satisfaction with product taste. The TASTY scale is a seven-item Likert scale, with visual graphics that are then coded numerically for a taste score.
• Parent/Guardian Satisfaction with Acceptability of Treatment [Parent/guardian satisfaction with acceptability of treatment will be recorded immediately post-treatment at the initial (Baseline) visit, with scores compared to Baseline at 3 months, 6 months, and an optional 12 months.]: Parent/guardian acceptability of treatment will be measured using a published, 4-item, 5-level Likert-scale assess feelings about the application procedure. The scale is scored from Strongly Agree to Strongly Disagree for the following items: * The study product application is an easy process. * I am comfortable with discoloration of cavities after study product placement. * The study product application as pain free for my child. * The taste of the study product was acceptable to my child.
• Provider Satisfaction with Product Use [The study examiners will complete the Provider Satisfaction with Product Use at the end of the study only (6 months, and/or optional 12 months)]: Sstudy examiners will provide their feedback about ease of product use/ performance using a Likert scale, scored from Strongly Agree to Strongly Disagree. * It was easy for me to identify which product was applied due to the degree of post-treatment staining of the carious lesion. * " " to the degree of post-treatment staining of the surrounding soft tissues. * There was a noticeable difference between the two products based on their efficacy with arresting the carious lesion(s). The same Likert scale will be used to score each product (SDF and NSF): * The study product application was easy. * " " was time-efficient. * The study product performance with arresting caries was satisfactory with one treatment. * The children seemed to tolerate this product well. * " " appeared dissatisfied with the appearance of their tooth/teeth after treatment. * " " with the taste of the product after treatment. * I intend to continue use of the product...
• Incidence of Adverse Events [Adverse events will be reported immediately post-treatment at the initial (Baseline) visit, and at all study visits: 3 months, 6 months, and optional 12 month visit.]: The presence/absence of adverse events will be assessed and documented immediately after product application and at all timepoints. Adverse events include taste alteration, pulpal and soft tissue irritation, permanent staining of adjacent teeth and restorations, and temporary staining of soft tissues (intraoral: mucosa, tongue, gingiva; extraoral: lips, cheeks). Adverse events are scored dichotomously (present/absent). Photography may be used as part of documentation for severe adverse events.. Severe adverse events will be managed accordingly and reported to the IRB, sponsor and appropriate regulatory bodies.
• Status of Child's Oral Hygiene Behaviors [The child subject's oral hygiene behaviors are assessed at Baseline only.]: The child subject's oral hygiene behaviors will be assessed for the potential to influence caries risk. Behaviors will be reported by the children's parents/guardians and includes: Fquency of daily toothbrushing (None 1, 2, more than 2 times); How does their child brush their teeth (Child brushes their own teeth (unsupervised brushing), Both the child and parent brush the child's teeth, Parent brushes the child's teeth, Child brushes their own teeth but the parent watches (supervised brushing); Use of fluoridated toothpaste (yes, no, I don't know); Brand of toothpaste used (enter brand name or I don't know); Drinks fluoridated water (yes, no); and zipcode of primary residence (enter 5 digits - used to confirm if city/town has community-fluoridated water).
• Status of Child's Daily Sugar Consumption Score [The Child's Daily Sugar Consumption Score will be recorded at the initial (Baseline) visit only.]: The child subject's parent/guardian will report the child's intake of eight different sugary foods and beverages. Higher scores represent higher caries risk. The eight categories of foods and beverages assessed include: Candies, fruit roll-ups; Cookies and cakes; Fruit: fresh fruit, fruit cocktail; Sugar-added chewing gums; Jam, Jelly or Honey; Carbonated beverages (sodas); Sugar-sweetened milk; and Sweetened hot drinks. The paret/guardian will mark each category that their child consumes on a daily basis. The number of categories will be calculated and documented.
• Number of Child Subject's Dental Visits in the Past Year [The number of the child subject's dental visits in the past year will be recorded at the initial (Baseline) visit only.]: The number of dental visits that the child had in the past year will be documented, and whenever possible, will be confirmed via chart and/or provider audit. Receipt of regular professional care may influence caries risk.

Sex: All, ages: 6 Years to 10 Years

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.

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• Study Protocol: Original Study Protocol (PDF, 2026-06-24)