Clinical Trial: The Use of Platelet Rich Fibrin in Pulpal and Periodontal Regeneration in Mature Teeth
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: The Use of Platelet Rich Fibrin in Pulpal and Periodontal Regeneration in Mature Teeth
Brief Summary: In cases of permanent tooth avulsion, it is widely accepted that some necrosis always occurs after avulsion injury. If the pulp tissue does not revascularize or if endodontic therapy is not performed, the pulp space can become infected. Platelet rich fibrin (PRF) is a second generation platelet concentrate that allows the clinician to obtain fibrin membranes enriched with platelets and growth factors from an anticoagulant-free blood harvest. Clinical relevance of PRF and revascularization has been demonstrated in several case studies of avulsion. To date no human clinical trials have been performed evaluating the effectiveness of PRF on pulpal revascularization after reimplantation and its benefits in limiting inflammation. The following study consists of two phases: Phase 1: An in vitro model evaluating the effects of PRF in limiting inflammatory response of pdl cell cultures in the presence of an inflammatory mediators. Phase 2: An in vivo model utilizing mature teeth previously treatment planned for extraction, treating with PRF, reimplanting teeth and following for three to four months before extracting and performing histological analysis. If PRF is capable of promoting revascularization in mature teeth the potential benefits extend to limiting the need for endodontic therapy following mature tooth avulsion, potential for mature tooth transplantation in situations of congenitally missing teeth, and utilization of PRF in endodontic revascularization therapy.
Detailed Summary:
When a tooth is avulsed, it is separated from its socket causing damage to the attachment apparatus. The periodontal ligament (pdl) is a group of specialized connective tissue fibers that attaches the cementum of the root (outer layer) to the alveolar bone. Avulsion can cause damage to the pdl and possible cemental tears. If the periodontal ligament is left attached to the root and minimal time lapse occurs damage to the tissues is usually limited. In these cases, reimplantation is a widely accepted treatment; however the long term success of an avulsed tooth is dependent on various factors. When excessive drying occurs prior to re-implantation, a severe inflammatory response is elicited directly on the root surface which may result in osseous replacement or replacement resorption. Some necrosis always occurs after avulsion injury, and while the necrotic pulp is of little consequence, this necrotic tissue is at high risk for bacterial contamination. If the pulp tissue does not revascularize or if endodontic therapy is not performed, the pulp space can become infected. It has been suggested that treatment strategies should attempt to limit peri-radicular inflammation therefore promoting favorable cemental healing and limiting unfavorable osseous replacement.
Platelet rich fibrin (PRF) is a second generation platelet concentrate that allows the clinician to obtain fibrin membranes enriched with platelets and growth factors from an anticoagulant-free blood harvest and without the addition of artificial biochemical modification. PRF has demonstrated clinical relevance through its ability to stimulate cell proliferation of osteoblasts, gingival fibroblasts, and periodontal ligament (PDL) cells. In addition, PRF has been shown to limit epithelial cell growth therefore promoting connective tissue and alveolar bone regeneration and inhibiting epithelial proliferation. These prope
Sponsor: University of Nebraska
Current Primary Outcome: vitality (cold, percussion, EPT test) [ Time Frame: 3-4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Nebraska
Dates:
Date Received: May 26, 2015
Date Started: September 2014
Date Completion:
Last Updated: June 7, 2016
Last Verified: June 2016
