The Molecular Anatomy of Oral Wound Healing
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|ClinicalTrials.gov Identifier: NCT01078467|
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : December 3, 2019
- Two important properties distinguish the healing process of skin wounds from that of wounds of the mucous membranes of the mouth (oral mucosa). Although the skin and the oral mucosa tissues are similar in nature, oral mucosa have more rapid healing and a lack of scar tissue formation. However, oral wound healing in general has been poorly studied, and more information is needed to determine how specific aspects of the oral environment affect the healing process.
- Researchers are interested in identifying various factors that contribute to oral wound healing. Studying this process would help researchers explore procedures to accelerate the healing of critically-sized oral lesions formed by trauma, surgery, radiation therapy, infection, and other damage to the mouth. In addition, research into scar-free healing could be applied to other mucosal sites to promote healing and minimize unsightly scars that may compromise the tissue.
- To identify the specific factors that enable rapid and nearly scar-free healing of oral mucosa.
- Healthy male volunteers between 18 and 40 years of age.
- Regular cigarette, cigar, and pipe smokers; occasional smokers who smoke more than 1 day a week or have smoked in the prior month; users of chewing tobacco or betel nut; and heavy drinkers (three or more alcoholic drinks per day) will be excluded.
- Participants will have a medical history and examination, and will provide blood samples at the start of the study.
- Participants will provide oral mucosa samples from the inside of the cheek, taken using a dermal punch. At the same time, participants will provide skin biopsy samples of approximately the same size. After the skin and oral mucosa samples are taken, participants will be divided into three groups for follow-up procedures.
- Group 1: No further samples will be collected. This group will help document the normal healing process.
- Group 2: A second, slightly larger biopsy, which will include the area of the first biopsy, will be taken on day 3. Both skin and oral mucosa biopsies will be taken.
- Group 3: A second, slightly larger biopsy will be taken on day 6, in a similar way as described for Group 2. Both skin and oral mucosa biopsies will be taken.
- Wounds will be photographed with a digital camera on days 3, 6, 9, 13, and 15; and the healing will be monitored at the scheduled clinic visits.
|Condition or disease|
|Wounds and Injuries Wound Healing Ulcer|
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||The Molecular Anatomy of Oral Wound Healing|
|Study Start Date :||February 2, 2010|
|Study Completion Date :||February 19, 2019|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078467
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Janice S Lee, DDS, MD||National Institute of Dental and Craniofacial Research (NIDCR)|