Viewing Study NCT00000111



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Last Modification Date: 2024-10-26 @ 9:01 AM
Study NCT ID: NCT00000111
Status: UNKNOWN
Last Update Posted: 2005-06-24
First Post: 2000-01-18

Brief Title: Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites
Sponsor: National Center for Research Resources NCRR
Organization: National Center for Research Resources NCRR

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 2000-09
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 patients cells we can make larger pieces of oral tissue than we could have gotten directly from the patients 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
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
M01RR000042 NIH None httpsreporternihgovquickSearchM01RR000042