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Long lasting treatment for gingivitis

Grant number: 11/09849-3
Support Opportunities:Scholarships abroad - Research
Effective date (Start): November 15, 2011
Effective date (End): November 14, 2012
Field of knowledge:Health Sciences - Dentistry - Periodontology
Principal Investigator:Francisco Carlos Groppo
Grantee:Francisco Carlos Groppo
Host Investigator: J. Max Goodson
Host Institution: Faculdade de Odontologia de Piracicaba (FOP). Universidade Estadual de Campinas (UNICAMP). Piracicaba , SP, Brazil
Research place: Forsyth Institute, United States  
Associated research grant:06/00121-9 - New formulations for the controlled release of local anesthetics in dentistry: from development to clinical tests, AP.TEM

Abstract

Periodontal diseases affect a large percentage of the adult population. The chronic inflammatory nature of this disease creates a cascade of inflammatory mediators that are both locally and systemically destructive, contributing to heart disease, stroke, rheumatoid arthritis, low birth-weight babies and possibly gastro-intestinal diseases. The inflammatory mediators also contribute to changes within the oral biofilm (dental plaque). The inflammatory by products of these bacteria increase the loss of bone support ultimately leading to tooth loss. Treating periodontal diseases with systemic agents is often ineffective as these agents are often short acting and dispense low concentrations of drug at the site of infection/inflammation in the oral cavity. A locally administered sustained release anti-inflammatory and/ or anti-infective agent can reduce the inflammatory mediators significantly and reduce the pathogenicity of the dental biofilm, while limiting patient exposure to unnecessary systemic levels of drugs. The aim of the present study is focused entirely on using a liposomal drug delivery system conjugated to the patented, long acting tissue-adhesive system (PLL) to develop a long lasting anti-inflammatory and /or anti-infective product to meet the substantial unmet medical needs faced by these patients. A proper mixture (ratio) of hyaluronic acid and polylysine (HA/PLL) formulation, the drug containing liposomes and the proper molecular weight of each ingredient will be primarily determined. Then, the residence time and efficacy will be established in a preliminary, twenty patient, human clinical study and determine if there is any tissue irritation. Additionally, we will establish the critical path for the rapid translation of the technology from the bench to FDA required clinical trials and ultimately to the market. (AU)

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