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临床试验/NCT04202822
NCT04202822已完成不适用

Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis Part I - Gene Expression and Cellular Behaviour 24-hours After Injury

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年4月1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
15
试验地点
2
主要终点
Changes from baseline fold regulation wound healing related genes at 24 hours

研究概览

简要总结

The purpose of the present study is to observe and compare -through a biomolecular analysis- the differences in the gene expression and cellular behavior in the early wound healing process -24 hours after injury- between the following three oral tissues: alveolar mucosa, buccal gingiva and palatal tissue.

The main hypothesis is that there is a difference in the gene expression and in the cellular behaviour between the three oral tissues studied and this difference can be observed at 24 hours post-injury.

详细描述

The wound healing is an extremely complex process. It has been observed that oral wounds mechanisms present special features. In fact, mucosal wounds demonstrated accelerated healing compared to cutaneous wounds.

Numerous comparative studies have described important differences of cellular behavior and genes expression between oral mucosal and dermal tissues. Moreover, it has been observed that the behavior of the cells is autonomous, i.e., that greatest differences seen in the genomic response after injury in skin and mucosa are derived, in part, from intrinsic differences in the genetic regulation of the cells at each site. Also, it is important to highlight the fact that it has been observed that the cellular response after wound is early, showing the first and greatest changes at 12-24 hours post injury. Moreover, a recent study has been raised the possibility of that the transcriptional regulatory networks responsible for the accelerated healing in oral mucosa are already present in the unwounded state.

In the oral mucosal tissues, the mechanisms underlying scar-less wound healing have been studied. Most studies have focused on the cellular characteristics and the molecular expression as growing factors, inflammatory mediators, etc., and have evaluated the process in later periods.

Therefore, while the biomolecular basis of the differences in oral mucosal and dermal tissues wound healing have been described, this is less well understood in the different oral soft tissue wounds.

The following points must be considered:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients that required periodontal surgery;
  • patients age between 30-60 years;
  • patients with full mouth plaque score and full mouth bleeding score < 15%;
  • patients with a good general healthy status;
  • patients without any medicaments or drug consumption that can affect the healing process;
  • non-smoking patients.

排除标准

  • patients in pregnancy;
  • patients in lactation period;
  • patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months;
  • patients with systemic diseases.

结局指标

主要结局

Changes from baseline fold regulation wound healing related genes at 24 hours

时间窗: Baseline (T0) and 24 hours after surgery (T24)

Total RNA from biopsies or cell cultures was extracted using TRIzol reagent Quantitative real-time PCR (qRT-PCR) cDNA was generated and cDNA obtained were used for amplification of wound healing related genes using the appropriate TaqMan gene expression assay kits.

次要结局

  • Clinical evaluation of early wound healing(24 hours and 1 week after surgery)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Pilloni MD DDS MS

Chairman Section of Periodontics Director of Master Program in Periodontics

University of Roma La Sapienza

研究点 (2)

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