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Trial record 1 of 1 for:    NCT01078467
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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
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Brief Summary:


  • 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

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Study Type : Observational
Actual Enrollment : 53 participants
Time Perspective: Prospective
Official Title: The Molecular Anatomy of Oral Wound Healing
Study Start Date : February 2, 2010
Study Completion Date : February 19, 2019

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
  • 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.


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
  • 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<TAB>

Hemoglobin: <10; > 17.5gr/L<TAB>

Hematocrit: <30; >51%<TAB>

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

Information from the National Library of Medicine

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

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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)
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Principal Investigator: Janice S Lee, DDS, MD National Institute of Dental and Craniofacial Research (NIDCR)
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Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT01078467    
Other Study ID Numbers: 100020
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: February 19, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Wound Healing
Oral Wounds
Cutaneous Wounds
Gene Array Analysis
Proteomic Analysis
Healthy Volunteer
Additional relevant MeSH terms:
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Wounds and Injuries