The National Institute of Dental and Craniofacial Research (NIDCR) awarded a $1,196,355 Project Grant (CFDA 93.121 Oral Diseases and Disorders Research) to Regendodent, Inc. in Ann Arbor, Michigan. The grant will support the development of REGENDOGEL (RG), a new class of dental material that stimulates regeneration of dental pulp and dentin damaged by decay or trauma. The project aims to compare the original RG formulation using bovine-derived dentin matrix molecules (DMMs) with a new...
This Project Grant award of $408,375 from the National Institute of Dental and Craniofacial Research (NIDCR), under the Oral Diseases and Disorders Research program (CFDA 93.121), will fund research on a novel biomimetic nitric oxide and hydroxyapatite (NO-HA) duo for advanced direct pulp capping. The research aims to develop a synergistic solution that can enhance bioactive and physical-mechanical barrier functions to support pulp-dentin repair and preserve tooth vitality. Key objectives...
The University of Tennessee (UT) has been awarded a $423,500 Project Grant from the National Institute of Dental and Craniofacial Research (NIDCR) under the Oral Diseases and Disorders Research program (CFDA 93.121). The grant will fund the development and evaluation of a personalized bioprinting technology for de novo regeneration of the periodontal ligament (PDL) in avulsed (knocked out) permanent teeth. The key products and services to be delivered under this grant include: Optimization of...
The National Institute of Dental and Craniofacial Research (NIDCR), under the Oral Diseases and Disorders Research federal grant program (CFDA 93.121), awarded Matregenix Inc. a $976,000 project grant (Award ID R44DE035026) to develop MATRINOVA, an animal-free, amino acid-based biodegradable barrier membrane for guided bone regeneration in dental and craniomaxillofacial surgeries. The goal is to establish the efficacy and clinical significance of MATRINOVA, a bilayered membrane produced using...
The National Institute of Dental and Craniofacial Research (NIDCR) awarded a $435,167 Project Grant under the Oral Diseases and Disorders Research program (CFDA 93.121) to The Research Foundation For The State University Of New York (RF SUNY) for the project "DEVELOPMENT OF AN EARLY TOOTH ORGANOID VIA HUMAN INDUCED PLURIPOTENT STEM CELLS". The project aims to use human induced pluripotent stem cells (iPSCs) to derive clinically-relevant dental cell types and develop a robust human...
The National Institute of Dental and Craniofacial Research (NIDCR) awarded a $421,800 Project Grant under the Oral Diseases and Disorders Research program (CFDA 93.121) to Midwestern University. The purpose of this 3-year grant, with a start date of September 7, 2023, is to develop hybrid hydrogel-based dental adhesives that are less vulnerable to hydrolytic degradation compared to current methacrylate-based alternatives. The goal is to create a truly biomimetic dental adhesive that can not only...
This federal Project Grant award from the National Institute of Dental and Craniofacial Research (NIDCR), under the Oral Diseases and Disorders Research program (CFDA 93.121), provides $443,576 to the University of Washington to develop bioengineered 3D tooth germs for tooth regeneration research. The key objectives are to: 1) investigate how biomaterial composition and mechanical properties regulate stem cell renewal and support long-term growth of odontogenic epithelial stem cells and neural...
This Project Grant award from the National Institute of Dental and Craniofacial Research (NIDCR), under the Oral Diseases and Disorders Research federal grant program (CFDA 93.121), aims to develop high-performance, bisphenol A (BPA)-free dental restoration composites with remineralization capabilities. The $591,378 award was granted to Callentis Consulting Group LLC, a woman-owned small business in Austin, Texas, in collaboration with the University of Colorado and New Mexico State...
The National Institute of Dental and Craniofacial Research (NIDCR) awarded a $2,539,292 project grant under the Oral Diseases and Disorders Research federal grant program (CFDA 93.121) to the ADA Forsyth Institute, Inc. (The Forsyth Institute) to develop a novel operational platform and suite of multifunctional dental restoration materials. The key products and services to be delivered include: Creating a self-improving, universal dental adhesive that enhances its bond to tooth structure through...
This Project Grant award from the National Institute of Dental and Craniofacial Research (NIDCR), under the Oral Diseases and Disorders Research program (CFDA 93.121), provides $2,078,772 to Hydronovo, Inc. to conduct critical Investigational New Drug (IND)-enabling studies for their regenerative therapy CVGN8. CVGN8 is an injectable neuromimetic hydrogel that aims to restore salivary gland function in patients suffering from xerostomia (dry mouth), a condition often caused by radiation...
COMMERCIALIZATION OF THE VITAL-DENT REGENERATIVE PULP THERAPY - PROJECT SUMMARY/ABSTRACT OVER HALF OF ALL CHILDREN SEVERELY HURT THEIR TEETH THROUGH PHYSICAL INJURY OR CARIOUS LEGION, RESULTING IN THE PERFORMANCE OF 4.7M ENDODONTIC PROCEDURES PER YEAR IN THE PEDIATRIC AND YOUNG ADULT POPULATION. MAINTENANCE OF VITAL PULP IN THE TOOTH IS CRITICAL FOR THE ABILITY TO FIGHT FUTURE INFECTIONS, PREVENT FRACTURE, AND RETAIN THE TOOTH, PARTICULARLY FOR IMMATURE PERMANENT TEETH WITHOUT FULLY DEVELOPED ROOTS. EXISTING TREATMENT OPTIONS INCLUDE NON- VITAL THERAPIES, SUCH AS APEXIFICATION AND ROOT CANAL THERAPY, VITAL PULP THERAPIES, WHICH PRESERVE SOME EXISTING PULP BUT DO NOT MAINTAIN VITAL PULP THROUGHOUT THE DENTAL CANAL, AND REVASCULARIZATION THERAPY, WHICH SUFFERS FROM HIGH RATES OF ADVERSE EVENTS. TREATMENT WITH VITAL-DENT, A HYDROGEL MATERIAL THAT SUPPORTS THE REGENERATION OF VITAL PULP TISSUE FOR THE RESTORATION OF PULP THROUGHOUT THE DENTAL CANAL, WILL INCREASE TOOTH RETENTION AND PROMOTE RESISTANCE TO FRACTURE AND INFECTION. VITAL-DENT IS AN ACELLULAR, DRUG-FREE HYDROGEL THAT PROVIDES OBTURATION AND PULP REGENERATION FOR REGENERATIVE ENDODONTIC PROCEDURES. VITAL-DENT CONSISTS OF TWO BIOPOLYMERS (PORCINE DERIVED GELATIN WITH ADDED UNFRACTIONATED HEPARIN) AND PHOTOINITIATOR DISSOLVED IN SALINE. THE LIQUID HYDROGEL PRECURSOR IS PLACED INTO THE PULP CANAL AND THEN IS PHOTOCROSSLINKED. THE HYDROGEL WORKS AS A BARRIER TO INFLUX OF BLOOD INTO THE TREATED TOOTH ROOT, INHIBITING THE ACUTE INFLAMMATORY RESPONSE TO THROMBUS FORMATION, WITH THE GELATIN SUPPORTING CELLULAR MIGRATION INTO THE HYDROGEL FROM THE PERIAPICAL SPACE. THE HEPARIN SUPPLEMENT PROMOTES SWELLING OF THE GELATIN HYDROGEL TO ENSURE THE FULL OBTURATION AND THE BARRIER FUNCTION. THE EXTENSIVE TESTING COMPLETED TO DATE DEMONSTRATES THE REGENERATION OF PULP TISSUE AND MAINTENANCE OF TOOTH VITALITY WITH VITAL-DENT. PHASE I RESULTS SHOWED THAT VITAL-DENT DOUBLED THE INCIDENCE OF APEX CLOSURE RELATIVE TO REVASCULARIZATION. THIS IS THE PARAMOUNT OUTCOME FOR PEDIATRIC INDICATIONS, AS CONTINUED TOOTH DEVELOPMENT GREATLY INCREASES TOOTH SURVIVAL. THE WORK PROPOSED HERE REPRESENTS A SIGNIFICANT STEP TOWARDS BRINGING VITAL-DENT TO THE CLINIC. THE VITAL-DENT MANUFACTURING PROCESS WILL BE SCALED UP AND THE PRODUCT FORMULATION WILL BE OPTIMIZED TO INCLUDE CGMP PRECURSOR BIOMACROMOLECULES WHILE MAINTAINING THE EQUIVALENT PHYSICAL PROPERTIES AND BIOCOMPATIBILITY OF THE FINAL HYDROGEL. THIS AIM WILL RESULT IN THE MANUFACTURE OF A FULLY CGMP-COMPLIANT BATCH OF VITAL-DENT. THE MECHANICAL AND FUNCTIONAL PROPERTIES OF THE FINAL VITAL-DENT FORMULATION WILL BE CHARACTERIZED, AND AN IN VIVO STUDY WILL EVALUATE THE EFFECTIVENESS OF VITAL-DENT. FINALLY, WE WILL PERFORM BIOCOMPATIBILITY TESTING TO ASSESS FOR CYTOTOXICITY, SENSITIZATION POTENTIAL, IRRITATION, AND ACUTE AND SUBACUTE TOXICITY. THE PROPOSED STUDIES HAVE BEEN DESIGNED TO SUPPORT THE FILING FOR FDA CLEARANCE OF VITAL- DENT, A CRITICAL STEP TOWARDS ADOPTION OF VITAL-DENT.