Quick-Set Material-Phase II
Department of Health and Human Services
Agency Tracking Number:
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Small Business Information
7046 OWL'S NEST TERRACE, BRADENTON, FL, -
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): Quick-Set Material- Phase II Quick-Set material is proposed for vital pulp therapy and for non-vital endodontic use to make the clinical procedures shorter and more consistent, of benefit to the patient and clinician,and enhance the probability for a positive outcome. The new material should promote regeneration of the periodontal ligament and cemental tissues that are injured by endodontic infections or removed during endodontic procedures. Such regeneration of tissues enhances the biological seal of the root canal system to reduce the possibility of re-infection, and enhance tooth retention without further treatment, surgery, or extraction. The material is intended to be an improvement on the present standard of care, MTA material which suffers from clinical deficiencies of long setting times (hours), difficulty in placement and retention, lower than desired radiopacity, and inability to se under acid conditions. In Phase 1, Quick-Set was shown to set in about 10 minutes (not hours) and was demonstrated to have superior sealing (including penetration of dentinal tubules), higher radiopacity, and better resistance to acids present in infections. The Quick-Set material was shown to have an alkaline pH, release calcium ions, form hydroxyapatite in synthetic body fluids, and meet ADA 57 requirements as they apply. This Phase 2 project is to test the Quick-Set Material from Phase 1 for its biocompatibility and in vivo performance. This testing planned is to examine the biocompatibility using odontoblast-like cell cultures, and then expand the testing to performance in vivo with canines and rats. The canine study will compare Quick-Set to White MTA material in both vital and non-vital pulp indications. Calcified and decalcified histology will be augmented by measurement of bone regeneration determined by CT. The rat study will compare the healing performance of pulp infections between the two materials, using orofacial pain measurements (meal duration measurement) and ELIZA histology for markers of inflammation. The clinical handling and filling of roots and vital pulp treatments will be examined by the clinicians performing the animal studies, to ensure the material can meet clinical expectations. In parallel, a sealer formula (denoted herein as Quick-Set Sealer) will be developed in the laboratory. The sealer should have the same good qualities of Quick-Set, but should contain finer particles, meet all the requirements of ISO 6876 and ADA 57, and have a longer setting time, with handling similar to conventional root canal sealers. The Quick-Set sealer will be used in a second canine study with decalcified histology. Laboratory testing will also be performed to increase the strength measurements of Quick-Set and develop paste-based formulas. PUBLIC HEALTH RELEVANCE: Quick-Set Material, Phase II Quick-Set material is being developed to enable dentists treating the infected pulp of teeth or their roots to complete the procedures more quickly and with better results. Manyuses are planned for Quick-Set material to heal infected pulps and root infections, with the goal of retaining teeth and reducing the need for other procedures such as extraction or implants. The Quick-Set material is designed to be quicker-setting, evenwhen an infection is present, and to seal and heal teeth better than existing materials.
* information listed above is at the time of submission.