RegendoGEL for guided pulp and dentin regeneration

Regendodent, Inc., Ann Arbor MI

Investigators

Abstract

Project summary/abstract RegendoGEL (RG) is a new class of dental material that stimulates both dental pulp and dentin regeneration via the biological activities of natural tooth-derived proteins. RG is being developed to regenerate dental pulp and dentin damaged by decay or trauma. RG is envisioned as a novel product to replace currently used nondegradable silicate cements. RG will initially be validated for use in vital pulp therapy, and eventually for full endodontic root canal therapy and dentin restoration. Clinically, RG will be applied in the same manner as currently used products for vital pulp and pulpotomy therapies. RG stimulates the guided regeneration of the pulp dentin complex, as validated in in vitro and in three different in vivo animal models. RG induces rapid and controllable formation of a reparative dentin bridge immediately adjacent to the product, while at the same time promoting controlled and non-inflammatory regeneration of the underlying dental pulp. RG therefore enables “controlled and guided” regeneration of pulp and dentin at predetermined locations, a concept that is akin to periodontal guided tissue regeneration therapies. The proposed STTR award will compare the original RG, which was formulated using bovine-derived dentin matrix molecules (DMMs), with a new formulation of RG containing porcine-derived DMMs. It is desirable from a cGMP manufacturing perspective to have animal-derived material from only one species. Also in Specific Aim 1, we will characterize and compare the effect of a direct restorative (resin-modified glass ionomer) on pulp and dentin regeneration in RG-MP treated teeth and compare that to teeth treated with both RG and MTA. In Specific Aim 2, we will characterize two antimicrobials: one inorganic colloidal silver nanoparticles, and the other polymeric in its composition, namely Epsilon-poly-L-lysine (ε-PL). We will then test the antimicrobial effect in a bacteria-challenged in vivo pulpotomy model. Ultimately, we propose that this combination of materials will result in the first and only biodegradable hydrogel product for endodontic therapy that is both antimicrobial, immunomodulatory and regenerative in the market.