Efficacy and safety of P11-4 for the treatment of periodontal defects in dogs

Claudine Bommer,Ronald Jung,Tobias Waller,Daniel Wiedemeier,Nina Meyer,Monika Hilbe,Stephanie Mathes

doi:10.1007/s00784-021-04297-6

Abstract

ObjectivesThis study’s aim was to investigate the safety and performance of a self-assembling peptide matrix (SAPM) P11-4 for the treatment of periodontal disease in a controlled pre-clinical study.Materials and methodsAcute buccal bony dehiscence defects (LxW: 5 × 3 mm) were surgically created on the distal root of four teeth on one mandible side of 7 beagle dogs followed by another identical surgery 8 weeks later on the contralateral side. SAPM P11-4 (with and without root conditioning with 24% EDTA (T1, T2)), Emdogain® (C) and a sham intervention (S) were randomly applied on the four defects at each time point. Four weeks after the second surgery and treatment, the animals were sacrificed, the mandibles measured by micro-computed tomography (µ-CT) and sections of the tissue were stained and evaluated histologically.ResultsClinically and histologically, no safety concerns or pathological issues due to the treatments were observed in any of the study groups at any time point. All groups showed overall similar results after 4 and 12 weeks of healing regarding new cementum, functionality of newly formed periodontal ligament and recovery of height and volume of the new alveolar bone and mineral density.ConclusionA controlled clinical study in humans should be performed in a next step as no adverse effects or safety issues, which might affect clinical usage of the product, were observed.Clinical relevanceThe synthetic SAPM P11-4 may offer an alternative to the animal-derived product Emdogain® in the future.

Highlights

A prospective candidate for the treatment of periodontal disease caused by inflammation in response to a dysbiotic shift in the oral biofilm [1,2,3,4] presents the family of rationally designed self-assembling peptides (SAPs) to support periodontium’s intrinsic regeneration potential
The present study focused on the performance and safety evaluation of a novel scaffold consisting of self-assembling peptide matrix (SAPM) P11-4 for the regeneration of alveolar bone, cementum and functional periodontal ligament in periodontal defects with the goal to restore periodontal attachment
In the present study the results of these two parameters taken together indicate a comparable efficacy of the investigational product SAPM P11-4 to today’s clinical gold standard enamel matrix derivative (EMD) and an enhanced efficacy compared to the sham control

Summary

Introduction

A prospective candidate for the treatment of periodontal disease caused by inflammation in response to a dysbiotic shift in the oral biofilm [1,2,3,4] presents the family of rationally designed self-assembling peptides (SAPs) to support periodontium’s intrinsic regeneration potential. A hydrogel of SAP P 11-4 matrix (SAPM P 11-4) was recently reported to be a suitable scaffold for dental follicle stem cells facilitating their proliferation, osteogenic differentiation and collagen type I expression in vitro [10]. Favourable cellular interactions of the SAP P11-4 scaffold were found with other periodontal cells such as human periodontal ligament fibroblasts and osteoblasts suggesting that a SAPM P11-4 hydrogel is an injectable, biocompatible and non-cytotoxic scaffold candidate for periodontal hard and soft tissue regeneration therapy. The SAPM P11-4 mimics the natural extracellular matrix with appropriate enzymatic and bacterial degradation characteristics found in the oral cavity [11,12,13]

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