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Protocol Details

The Molecular Anatomy of Oral Wound Healing

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-D-0020

Sponsoring Institute

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male
Min Age: 18
Max Age: 40

Referral Letter Required

Yes

Population Exclusion(s)

Female;
Children

Special Instructions

Currently Not Provided

Keywords

Wound Healing;
Oral Wounds;
Cutaneous Wounds;
Gene Array Analysis;
Proteomic Analysis

Recruitment Keyword(s)

Healthy Volunteer;
HV

Condition(s)

Wounds and Injuries;
Wound Healing;
Ulcer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Dental and Craniofacial Research

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.

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Eligibility

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

- 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


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Citations:

Sch(SqrRoot) fer M, Werner S. Transcriptional control of wound repair. Annu Rev Cell Dev Biol. 2007;23:69-92.

Baker H, Patel V, Molinolo AA, Shillitoe EJ, Ensley JF, Yoo GH, Meneses-Garc(SqrRoot)(NotEqual)a 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.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

J. Silvio Gutkind, Ph.D.
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 30
Room 211
30 Convent Drive
Bethesda, Maryland 20892
(301) 496-2069
gutkind@dir.nidcr.nih.gov

J. Silvio Gutkind, Ph.D.
National Institute of Dental And Craniofacial Research (NIDCR)
National Institutes of Health
Building 30
Room 211
30 Convent Drive
Bethesda, Maryland 20892
(301) 496-2069
gutkind@dir.nidcr.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT01078467

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