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Trial NCT00000111

Resource URI: http://static.linkedct.org/resource/trials/NCT00000111
linkedct:brief_title Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites
linkedct:condition <http://static.linkedct.org/resource/condition/8289>
linkedct:criteria Inclusion Criteria: - Lack sufficient attached keratinized tissue at recipient surgical site in question
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date January 18, 2000
linkedct:id NCT00000111
rdfs:label Trial NCT00000111
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Center for Research Resources (NCRR)
linkedct:nct_id NCT00000111
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NCRR-M01RR00042-1620
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000111>
linkedct:phase Phase 1
linkedct:secondary_id M01RR00042
linkedct:source National Center for Research Resources (NCRR)
linkedct:study_design Treatment, Randomized, Open Label, Parallel Assignment
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to see if we can develop a good graft for oral mucosal tissue that is like the top of the mouth in a "test tube" that could be used successfully in humans. We have already done this successfully mice. The next step is to take a small piece of tissue from a human volunteer and see if we can grow a larger piece of tissue from it outside the human body and graft it back into the same person successfully. We expect that this technique will work. It has already been tried in patients with burns of the skin who have had similar procedures where the skin is grafted back to them. The significance of this research is that oral tissue taken from the top of the mouth or palate is in limited supply and leaves the patient with a painful and uncomfortable post surgery experience. If we are successful with our technique the patient will experience less pain and discomfort from the site that we are using to grow our tissue outside the body than if we had taken it from the top of the mouth or palate. In addition, by waiting longer periods to grow the patient's cells we can make larger pieces of oral tissue than we could have gotten directly from the patient's mouth. Patients who will participate in this study will need to require a soft tissue graft from the mouth to an area that needs additional attached or keratinized mucosa. This will most likely be either in preparation for patients who have or will have dental implants placed. Another subset of patients are those who need scar tissue released or the vestibule of their mouth (area that turns from the gums to the lip) released.
rdf:type linkedct:trials
linkedct:verification_date September 2000