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

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.

Timeline

Start

2026-10-01

Primary completion

2028-10-31

Completion

2030-10-31

Publications

• Background 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.
• Background Viana 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.
• Background Cheng 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.
• Background Pahel 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.
• Background Michaeli 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.
• Background Nezam 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.
• Background Huang 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.

Drugs

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