drugset / Trial / NCT07829328
Can SAP P11-4 Affect The Appearance of Interproximal Cavities on an X-ray in a Military Population
NaSingle-groupOpen-labelPrevention
Summary
The primary objective of the protocol is to learn about how SAP P 11-4 (produced commercially as Curodont products) can be used in a military population to treat incipient dental caries, or developing cavities that are still structurally intact and not too deep and increase awareness of the improvement and availability of minimally invasive treatment options for cavities in a military population.
Timeline
- Start
- 2026-09-30
- Primary completion
- 2027-02
- Completion
- 2027-08
Publications
- Background Thakur S, Sojan M, Singhal P, Chauhan D. A Comparative Study to Evaluate the Effectiveness of Silver Diamine Fluoride at Different Time Durations of Application in Treating Carious Primary Teeth: A Randomized Trial. Int J Clin Pediatr Dent. 2022;15(Suppl 2):S147-S150. doi: 10.5005/jp-journals-10005-2326.
- Background Sleibi A, Tappuni A, Mills D, Davis GR, Baysan A. Comparison of the Efficacy of Different Fluoride Varnishes on Dentin Remineralization During a Critical pH Exposure Using Quantitative X-Ray Microtomography. Oper Dent. 2018 Nov/Dec;43(6):E308-E316. doi: 10.2341/18-014-L.
- Background Shaalan O, Fawzy El-Sayed K, Abouauf E. Evaluation of the remineralization potential of self-assembling peptide P11-4 with fluoride compared to fluoride varnish in the management of incipient carious lesions: a randomized controlled clinical trial. Clin Oral Investig. 2024 Jul 22;28(8):438. doi: 10.1007/s00784-024-05822-z.
- Background Pitts NB, Rimmer PA. An in vivo comparison of radiographic and directly assessed clinical caries status of posterior approximal surfaces in primary and permanent teeth. Caries Res. 1992;26(2):146-52. doi: 10.1159/000261500.
- Background Padilla-Caceres TC, Arbildo-Vega HI, Mamani-Cori V, Caballero-Apaza LM, Cruzado-Oliva FH, Farje-Gallardo CA, Marroquin-Soto C, Aguirre-Ipenza R, Vasquez-Rodrigo H, Lujan-Valencia SA, Meza-Malaga JM, Castillo-Cornock TB, Coronel-Zubiate FT. Effect of minimal intervention on carious lesions in primary teeth. An Umbrella review. Front Dent Med. 2026 Jan 12;6:1751752. doi: 10.3389/fdmed.2025.1751752. eCollection 2025.
- Background Mascarenhas AK. Is fluoride varnish safe?: Validating the safety of fluoride varnish. J Am Dent Assoc. 2021 May;152(5):364-368. doi: 10.1016/j.adaj.2021.01.013. Epub 2021 Mar 22.
- Background Magalhaes GAP, Fraga MAA, de Souza Araujo IJ, Pacheco RR, Correr AB, Puppin-Rontani RM. Effect of a Self-Assembly Peptide on Surface Roughness and Hardness of Bleached Enamel. J Funct Biomater. 2022 Jun 13;13(2):79. doi: 10.3390/jfb13020079.
- Background Kobeissi R, Badr SB, Osman E. Effectiveness of Self-assembling Peptide P11-4 Compared to Tricalcium Phosphate Fluoride Varnish in Remineralization of White Spot Lesions: A Clinical Randomized Trial. Int J Clin Pediatr Dent. 2020 Sep-Oct;13(5):451-456. doi: 10.5005/jp-journals-10005-1804.
- Background Diefenderfer KE, Stahl J. Caries remineralization therapy: implications for dental readiness. Mil Med. 2008 Jan;173(1 Suppl):48-50. doi: 10.7205/milmed.173.supplement_1.48.
- Background Dawasaz AA, Togoo RA, Mahmood Z, Azlina A, Thirumulu Ponnuraj K. Effectiveness of Self-Assembling Peptide (P11-4) in Dental Hard Tissue Conditions: A Comprehensive Review. Polymers (Basel). 2022 Feb 18;14(4):792. doi: 10.3390/polym14040792.
- Background Daruich PM, Brizuela M. Remineralization of Initial Carious Lesions. 2023 Apr 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK573067/
- Background Danisman H, Delikan E, Orhan K. Evaluation of the efficacy of P11-4 and CCP-ACPF in the prevention and treatment of white spot lesions: a multi-technique approach. Sci Rep. 2025 Apr 3;15(1):11512. doi: 10.1038/s41598-025-95781-6.
- Background Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | P11-4 | Peptide | — | Topical |
| Subject | sodium fluoride | Unknown | 0.05 % | Topical |