drugset / Trial / NCT07839780

S-PRG Filler for Preventing White Spot Lesions During Orthodontic Treatment

NCT07839780 ↗

Not yet recruiting 144 enrolled National University of Malaysia
RandomizedParallel-groupTriple-blindPrevention

Summary

White spot lesions are early areas of enamel demineralization that may develop during orthodontic treatment with fixed braces. This study aims to evaluate the effectiveness of S-PRG Barrier Coat in preventing white spot lesions during orthodontic treatment. The study will compare S-PRG Barrier Coat with 5% sodium fluoride varnish, a combination of S-PRG Barrier Coat and 5% sodium fluoride varnish, and a placebo. A total of 144 participants undergoing orthodontic treatment will be randomly assigned to one of four treatment groups. The occurrence and severity of white spot lesions will be assessed using clinical examinations, including the ICDAS-II and Gorelick index, together with DIAGNOdent readings where applicable. The study findings may help determine whether S-PRG Barrier Coat provides an effective preventive approach against orthodontic white spot lesions.

Timeline

Start
2026-10
Primary completion
2027-12
Completion
2028-01

Publications

  • Background Al Tuma, R. R. & Yassir, Y. A. 2023. Effect of calcium fluoride nanoparticles in prevention of demineralization during orthodontic fixed appliance treatment: a randomized clinical trial. Eur J Orthod 45(2): 122-132. Altenburger, M. J., Schirrmeister, J. F., Wrbas, K. T., Klasser, M. & Hellwig, E. 2008. Fluoride uptake and remineralisation of enamel lesions after weekly application of differently concentrated fluoride gels. Caries Res 42(4): 312-318. Amaechi, B. T., Kasundra, H., Joshi, D., Abdollahi, A., Azees, P. a. A. & Okoye, L. O. 2018. Effectiveness of S-PRG Filler-Containing Toothpaste in Inhibiting Demineralization of Human Tooth Surface. Open Dentistry Journal 12(811-819. Anderson, A. M., Kao, E., Gladwin, M., Benli, O. & Ngan, P. 2002. The effects of argon laser irradiation on enamel decalcification: An in vivo study. Am J Orthod Dentofacial Orthop 122(3): 251-259. Benham, A. W., Campbell, P. M. & Buschang, P. H. 2009. Effectiveness of pit and fissure sealants in reducing white spot lesions during orthodontic treatment. A pilot study. Angle Orthod 79(2): 338-345. Benjasuwantep, P., Rirattanapong, P. & Vongsavan, K. 2017.. Southeast Asian Journal of Tropical Medicine and Public Health 48(5): 1127-1132. Bishara, S. E. & Ostby, A. W. 2008. White Spot Lesions: Formation, Prevention, and Treatment. Seminars in Orthodontics 14(3): 174-182. Brown, M. D., Campbell, P. M., Schneiderman, E. D. & Buschang, P. H. 2016. A practice-based evaluation of the prevalence and predisposing etiology of white spot lesions. Angle Orthod 86(2): 181-186. Buchalla, W., Attin, T., Schulte-Mönting, J. & Hellwig, E. 2002. Fluoride uptake, retention and remineralization efficacy of a highly concentrated fluoride solution on enamel lesions . Journal of Dental Research 81(5): 329-333. Buren, J. L., Staley, R. N., Wefel, J. & Qian, F. 2008. Inhibition of enamel demineralization by an enamel sealant, Pro Seal: an in-vitro study. Am J Orthod Dentofacial Orthop 133(4 Suppl): S88-94. Chapman,

Drugs

EvaluationDrugModalityDoseRoute
Subject S-PRG Barrier Coat Other / unclassified — Topical
Comparator sodium fluoride Unknown 5 % Topical