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The Molecular Anatomy of Oral Wound Healing

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01078467
First received: February 27, 2010
Last updated: February 13, 2013
Last verified: July 2012
History of Changes
  Purpose

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.

Condition
Wounds and Injuries
Wound Healing
Ulcer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Molecular Anatomy of Oral Wound Healing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 27
Study Start Date: February 2010
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • 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.

EXCLUSION CRITERIA:

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
  • Sjogrens 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
  • Antithrombin III deficiency
  • Liver disease
  • Patients on medications that interfere with blood clotting or blood thinners. These medications include but are not limited to: ibuprofen aspirin, warfarin (Coumadin), ticlopidine (Ticlid), clopidogrel (Plavix), and others.
  • Subjects with clinically significant abnormal laboratory values will be ineligible

Complete blood count (CBC)

Platelet level: < 100 - > 500/ 10(3)/mcL

Hemoglobin: < 10; > 17.5gr/L

Hematocrit: < 30; > 51%

White blood cell count: < 3; > 12 10(3)/mcL

Partial thromboplastin time: < 20; > 42 sec

Prothrombin time: < 10; > 20 sec

C-reactive protein: > 4 mg/L

Erythrocyte sedimentation rate: > 40 ml/h

  • Recent unintentional weight loss of > 10 lbs over the past 6 weeks prior to screening
  • Have undergone general or oral surgery within the last 30 days
  • Treated with systemic steroids in the past 12 months
  • Subjects with a history of abnormal scar formation (i.e., keloids, hypertrophic scarring)
  • Subjects who have used tobacco products and/or betel nut within one month of the screening evaluation. Tobacco products include cigarette, pipe, cigar, and chewing tobacco
  • Heavy drinkers defined as drinking greater than or equal to alcoholic drinks per day
  • Subjects that, at the oral clinical examination, show any of the nonmalignant lesions associated with heavy smoking/tobacco chewing will be excluded. These findings include but are not limited to:
  • Tooth stains
  • abrasions
  • smoker's melanosis
  • acute necrotizing gingivitis
  • burns
  • erythematous or keratotic patches
  • black hairy tongue
  • nicotinic stomatitis
  • palatal erosions
  • Subjects with preneoplastic (leukoplakia, erythroplakia, submucous fibrosis) or neoplastic lesions
  • Subjects with known or suspected allergies or adverse reactions to any of the agents used for skin preparation, local anesthesia, or pain control or with known or suspected allergy or adverse reaction to Prolene (polypropylene) sutures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078467

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: J. Silvio Gutkind, Ph.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT01078467     History of Changes
Other Study ID Numbers: 100020, 10-D-0020
Study First Received: February 27, 2010
Last Updated: February 13, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Wound Healing
Oral Wounds
Cutaneous Wounds
Gene Array Analysis
 Proteomic Analysis
Healthy Volunteer
HV

Additional relevant MeSH terms:
Ulcer
Wounds and Injuries
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013