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临床试验/NCT01078467
NCT01078467已完成不适用

The Molecular Anatomy of Oral Wound Healing

National Institute of Dental and Craniofacial Research (NIDCR)1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2010年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1

研究概览

简要总结

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.

详细描述

BACKGROUND:

Two important properties distinguish the process of healing of oral mucosa wounds from those of the skin: more rapid healing and the absence of scar tissue formation. This is remarkable given the apparent similarities of the two tissues. There are, however, prominent differences in the healing environment, such as hydration, growth factor availability, inflammatory response, and microbial exposure. Knowledge as to the causal contribution of each of these factors to the differential healing response of the two epithelia is mostly anecdotal, and oral wound healing has generally been poorly studied. This study seeks to provide a global molecular definition of oral wound healing in comparison to that of the skin. The overall aim will be to identify the specific factors that enable rapid and nearly scar-free healing of oral mucosa. Identification of these physiological and molecular determinants will have widespread implications for human oral health. Among others, it would provide venues for the targeted exploration of procedures to accelerate the healing of critically-sized oral lesions formed by trauma, surgery, radiation therapy, infection, and other oral pathologies, which, if untreated, lead to permanent disability and dysfunction. Moreover, pathways and/or molecules identified in these studies which may facilitate rapid, scar-less healing could be considered for application to non-oral mucosal sites to promote healing and minimize unsightly scars, which may also compromise the functional integrity of the tissue.

Hypotheses:

  • There are significant differences in gene and protein expression between wound healing in skin and oral mucosa.
  • The recruitment of inflammatory cells associated with a large up-regulation of inflammation-associated genes, including cytokines and chemokines, in the epithelial cells of skin wounds may account for these differences.
  • There are specific gene programs that can explain the presence of significant scarring in skin tissues but not in oral mucosa.

OBJECTIVES:

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究者

发起方
National Institute of Dental and Craniofacial Research (NIDCR)
申办方类型
Nih
责任方
Sponsor

研究点 (1)

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