The Molecular Anatomy of Oral Wound Healing

NCT01078467 | Completed

• 2 other identifiers: 10002010-D-0020
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• 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. Objectives: \- To identify the specific factors that enable rapid and nearly scar-free healing of oral mucosa. Eligibility:
• 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. Design:
• 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.

Conditions

Wounds and Injuries; Wound Healing; Ulcer

Keywords

Wound Healing; Oral Wounds; Cutaneous Wounds; Gene Array Analysis; Proteomic Analysis; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers age 18 to 40.
• All volunteers must sign informed consent indicating their understanding that specimens and demographic information will be collected solely for research purposes.

You may not qualify if:

• Subjects with known inflammatory, chronic, and infectious diseases. These conditions include but are not limited to:
• Diabetes
• Heart failure
• Pulmonary disease
• Rheumatoid arthritis
• Systemic lupus erythematosus
• Sarcoidosis
• Sj(SqrRoot)(Delta)grens syndrome
• Dermatomyositis
• Psoriasis
• Cellulitis
• Patients with known bleeding disorders or conditions associated with bleeding. These conditions include but are not limited to:
• Hemophilia
• von Willebrand disease
• Protein C/S deficiency

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Schafer M, Werner S. Transcriptional control of wound repair. Annu Rev Cell Dev Biol. 2007;23:69-92. doi: 10.1146/annurev.cellbio.23.090506.123609.

  PMID: 17474876 BACKGROUND

• Baker H, Patel V, Molinolo AA, Shillitoe EJ, Ensley JF, Yoo GH, Meneses-Garcia A, Myers JN, El-Naggar AK, Gutkind JS, Hancock WS. Proteome-wide analysis of head and neck squamous cell carcinomas using laser-capture microdissection and tandem mass spectrometry. Oral Oncol. 2005 Feb;41(2):183-99. doi: 10.1016/j.oraloncology.2004.08.009.

  PMID: 15695121 BACKGROUND

• Lee HG, Eun HC. Differences between fibroblasts cultured from oral mucosa and normal skin: implication to wound healing. J Dermatol Sci. 1999 Nov;21(3):176-82. doi: 10.1016/s0923-1811(99)00037-7.

  PMID: 10527379 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Ulcer

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janice S Lee, DDS, MD

  National Institute of Dental and Craniofacial Research (NIDCR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2010
• First Posted: March 2, 2010
• Study Start: February 2, 2010
• Study Completion: February 19, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-02-19

Locations

US (1)