A Novel Proline-rich Peptide Hydrogel for Periodontal Regeneration in Adult Periodontitis Patients

Summary

The goal of this clinical trial is to learn if a novel peptide-rich hydrogel works to achieve periodontal regeneration in adults. It will also learn about the safety of the hydrogel. The main questions it aims to answer are: * Does the novel peptide hydrogel achieve periodontal regeneration to a similar degree as another currently used therapy (hyaluronic acid)? * What medical problems, if any, do participants have when receiving the novel hydrogel treatment? Researchers will compare the novel peptide hydrogel to another commonly used hydrogel (hyaluronic acid) to see if the peptide hydrogel works to treat periodontal bone defects. Participants will: * Receive the novel hydorgel or hyaluronic acid when they undergo periodontal regenerative surgery * Visit the clinic at regular intervals for 1 year after the surgery for follow ups

Timeline

Start

2026-11-01

Primary completion

2029-06-30

Completion

2030-06-30

Publications

• Background Zhu H, Gomez M, Xiao J, Perale G, Betge F, Lyngstadaas SP, Haugen HJ. Xenohybrid Bone Graft Containing Intrinsically Disordered Proteins Shows Enhanced In Vitro Bone Formation. ACS Appl Bio Mater. 2020 Apr 20;3(4):2263-2274. doi: 10.1021/acsabm.0c00064. Epub 2020 Mar 13.
• Background Ovrebo O, Lyngstadaas SP, El Khassawna T, Jamous R, Ma Q, Munoz F, Permuy M, Cantalapiedra AG, Serrano-Munoz AJ, Ramis JM, Monjo M, Rossi F, Haugen HJ. Multiomics Comparison of Proline-Rich Peptide-Enhanced Hyaluronic Acid Gels Versus Conventional Regenerative Materials: An Early Wound-Healing Model. J Periodontal Res. 2025 Oct;60(10):1018-1038. doi: 10.1111/jre.70032. Epub 2025 Sep 10.
• Background Villa O, Wohlfahrt JC, Mdla I, Petzold C, Reseland JE, Snead ML, Lyngstadaas SP. Proline-Rich Peptide Mimics Effects of Enamel Matrix Derivative on Rat Oral Mucosa Incisional Wound Healing. J Periodontol. 2015 Dec;86(12):1386-95. doi: 10.1902/jop.2015.150207. Epub 2015 Aug 7.
• Background Saiz AM, Rahmati M, Johnson SD, Bhat AS, Baldini TD, Ovrebo O, Nogueira LP, Khassawna TE, Stotzel S, Fierro FA, Lee MA, Leach JK, Haugen HJ. Systemic versus local delivery of mesenchymal stem cells to improve the early stages of fracture healing in a polytrauma model. J Biol Eng. 2025 Sep 30;19(1):82. doi: 10.1186/s13036-025-00554-4.
• Background Saiz AM, Rahmati M, Baldini TD, Satish Bhat A, Johnson SD, Liu M, Reyes RM, Fok SW, Lee MA, El Khassawna T, Wieland DCF, Marinho AL, Blanchet C, Leach JK, Haugen HJ. Mesenchymal stem cells delivered via a bioactive disordered peptide-hydrogel platform modulate early inflammation and enhance skeletal repair in a polytrauma model. J Tissue Eng. 2025 Dec 1;16:20417314251397106. doi: 10.1177/20417314251397106. eCollection 2025 Jan-Dec.
• Background Lyngstadaas SP, Wohlfahrt JC, Brookes SJ, Paine ML, Snead ML, Reseland JE. Enamel matrix proteins; old molecules for new applications. Orthod Craniofac Res. 2009 Aug;12(3):243-53. doi: 10.1111/j.1601-6343.2009.01459.x.

Drugs

Indications