Dental CariesNCT07861321
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
A study testing Nano Silver Fluoride / NSF in people with Dental Caries, run by A.T. Still University of Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Nano Silver Fluoride / NSF
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Oct 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marc Shlossman Associate Director of Clinical Research, DDS, MS contact
Ann Eshenaur Spolarich Professor and Assistant Dean for Research, RDH, PhD contact
United States1 site, 1 recruiting
- Recruiting
Arizona School of Dentistry & Oral Health (ASDOH), A.T. Still University
Mesa, Arizona, 85206
Marc Shlossman, DDS, MS, 480-248-8153, mshlossman@atsu.edu
About this study
Official title: A Randomized Controlled Trial to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
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
- Being tested
- Nano Silver Fluoride / NSF
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano Silver Fluoride / NSFDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (Nano Silver Fluoride / NSF) | Experimental | Participants receive a single topical application of ClearDefense® (3% sodium fluoride + 0.2% silver ion) to active carious lesions Receives: Device: Nano Silver Fluoride / NSF |
| Active Comparator Arm (Silver Diamine Fluoride / SDF) | Active comparator | Participants receive a single topical application of AdvantageArrest® (38% silver diamine fluoride) to active carious lesions Receives: Device: Nano Silver Fluoride / NSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (11)
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
Measured: 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
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.
Measured: 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.
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.
Measured: The status of the child's behavior is recorded post-treatment at the initial (Baseline) visit only.
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).
Measured: 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.
Status of Child Satisfaction with Product Taste (Patient Reported Outcome Measure)
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.
Measured: The child's TASTY score will be recorded immediately post-treatment at the initial (Baseline) visit only.
Parent/Guardian Satisfaction with Acceptability of Treatment
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.
Measured: 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.
Provider Satisfaction with Product Use
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...
Measured: 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)
Incidence of Adverse Events
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.
Measured: 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.
Status of Child's Oral Hygiene Behaviors
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).
Measured: The child subject's oral hygiene behaviors are assessed at Baseline only.
Status of Child's Daily Sugar Consumption Score
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.
Measured: The Child's Daily Sugar Consumption Score will be recorded at the initial (Baseline) visit only.
Number of Child Subject's Dental Visits in the Past Year
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.
Measured: The number of the child subject's dental visits in the past year will be recorded at the initial (Baseline) visit only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Oct 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861321
- Sponsor's protocol ID
- ATSU-YI-NSF 2025
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to outside researchers, as the protocol limits data access strictly to authorized study personnel and the study sponsor. All clinical findings will be de-identified, maintained on secure university servers, and reported exclusively in aggregate form to safeguard participant confidentiality. Furthermore, in accordance with institutional data management procedures, all electronic study records will be permanently deleted three years following trial completion.
Publications
Mortazavi SMJ. Re: Are electromagnetic fields in incubators a risk factor for autism? Acta Paediatr. 2017 Dec;106(12):2063. doi: 10.1111/apa.14055. Epub 2017 Sep 24. No abstract available.
PubMed 28862780Viana PHL, Schvarcz CA, Danics LO, Besztercei B, Aloss K, Bokhari SMZ, Giunashvili N, Bocsi D, Koos Z, Benyo Z, Hamar P. Heat shock factor 1 inhibition enhances the effects of modulated electro hyperthermia in a triple negative breast cancer mouse model. Sci Rep. 2024 Apr 8;14(1):8241. doi: 10.1038/s41598-024-57659-x.
PubMed 38589452Cheng Y, Wang T, Lv X, Li R, Yuan L, Shen J, Li Y, Yan T, Liu B, Wang L. Detection of PD-L1 Expression and Its Clinical Significance in Circulating Tumor Cells from Patients with Non-Small-Cell Lung Cancer. Cancer Manag Res. 2020 Mar 19;12:2069-2078. doi: 10.2147/CMAR.S245425. eCollection 2020.
PubMed 32256114Pahel BT, Rozier RG, Slade GD. Parental perceptions of children's oral health: the Early Childhood Oral Health Impact Scale (ECOHIS). Health Qual Life Outcomes. 2007 Jan 30;5:6. doi: 10.1186/1477-7525-5-6.
PubMed 17263880Michaeli L, Davis DM, Foxton R. Denture loss: an 8-month study in a community dental setting. Gerodontology. 2007 Jun;24(2):117-20. doi: 10.1111/j.1741-2358.2007.00133.x.
PubMed 17518960Nezam S, Mukherjee CG, Shukla JN, Jha A, Khan SA, Tanwar AS. Comparative Evaluation of Efficacy of Obturation Techniques in Deciduous Teeth Using Cone-beam Computed Tomography: An In Vivo Study. Int J Clin Pediatr Dent. 2021 Jan-Feb;14(1):75-80. doi: 10.5005/jp-journals-10005-1897.
PubMed 34326588Huang X, Yang X, Huang J, Wei L, Mao Y, Li C, Zhang Y, Chen Q, Wu S, Xie L, Sun C, Zhang W, Wang J. Correction: Human amnion mesenchymal stem cells promote endometrial repair via paracrine, preferentially than transdifferentiation. Cell Commun Signal. 2024 Jun 13;22(1):326. doi: 10.1186/s12964-024-01706-7. No abstract available.
PubMed 38872205