Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites
Primary Purpose
Mouth Diseases
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Oral mucosal graft
Sponsored by
About this trial
This is an interventional treatment trial for Mouth Diseases focused on measuring mouth mucosa, transplants
Eligibility Criteria
Inclusion Criteria: Lack sufficient attached keratinized tissue at recipient surgical site in question
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000111
First Posted
January 18, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00000111
Brief Title
Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites
Study Type
Interventional
2. Study Status
Record Verification Date
September 2000
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mouth Diseases
Keywords
mouth mucosa, transplants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Oral mucosal graft
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Lack sufficient attached keratinized tissue at recipient surgical site in question
12. IPD Sharing Statement
Learn more about this trial
Intraoral Grafting of Ex Vivo Produced Oral Mucosal Composites
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