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临床试验/NCT02540590
NCT02540590已完成不适用

Evaluation of Laser Speckle Contrast Imaging for Assessment of Oral Mucosal Blood Flow Following Periodontal Plastic Surgery: an Exploratory Observational Study

Semmelweis University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Postoperative blood flow changes of the oral mucosa

研究概览

简要总结

Our overall goal is to characterize the role of the microcirculation in healing oral mucosa after routinely applied surgery intervention in order to facilitate treatment. Using Laser Speckle Contrast Analysis (LASCA), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation in case of wound healing. After periodontal surgery, by means of the detection of microcirculation as a prognostic and diagnostic factor, the investigators can follow-up the healing procedure and obtain data so as to design e.g. the incision line that takes microvascular anatomy into account, thus result in better wound healing later on.

详细描述

In today's periodontal plastic surgery numerous flap designs with various grafting alternatives (auto-allo- or xeno-grafts) are routinely applied. In order to achieve uneventful primary intention healing and to allow for graft integration resulting in successful clinical outcomes it is important to apply optimized surgical techniques with suitable graft materials to address various clinical demands (e.g. recession coverage, enlargement of keratinized tissues, correction of periimplant soft tissue deficiencies). Graft exposure during soft- and hard tissue augmentation might occur before any chance of graft vascularization due to wound healing disturbances and lack of primary intention healing. The reasons of flap failure could be compromised flap circulation, which can be avoided by proper flap design, tension free flap advancement. The role of flap design on the gingival blood flow was investigated after surgery and found that the simplified papilla preservation flap resulted in faster recovery of the blood flow than the modified Widman flap surgery. In order to minimize trauma on surrounding tissues (i.e. flap) it is recommendable to use the least invasive method for flap preparation, which may also protect the underlining graft tissue and support quick vascularization. These guidelines led to develop a minimal invasive flap design for root coverage surgery, namely supraperiosteal envelope Tunnel technique, which was later modified by Azzi et al. to coronally advance the mucogingival complex in order to cover the inserted graft. Later it was further modified by introducing microsurgical approach. The question still remains to be answered how the Tunnelling technique can influence microcirculation of the healing gingiva and how the underlying graft tissue affects the overlying mucosal flap.

Recently a new non-invasive, two dimensional method, namely the laser speckle contrast analysis (LASCA) has been introduced to evaluate microcirculation of tissue. Clinical pilot studies are suggesting that this technique may be useful tool for assessing the proper circulation during surgical intervention and evaluating wound healing in the skin in human. This new method may let us monitor the entire surgical area real-time before and during the healing period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having thin gingival biotype.
  • Clinical diagnosis of multiple gingival recession
  • Good general health

排除标准

  • pregnancy,
  • general diseases,
  • take any antibiotics, antiinflammatory drugs, systemic steroids, biphosphonates, or any other medicines possibly influencing mucosal wound healing or any other products in the last three months (except contraceptives)

结局指标

主要结局

Postoperative blood flow changes of the oral mucosa

时间窗: 6 months after surgery

The blood flow changes were measured by Laser Speckle Contrast Analyzer (LASCA) before and after root coverage surgery (modified coronally advanced technique). The scale was an arbitrary unit (0-3000 LSPU) and the relative changes to the pre-operative measurement were calculated. Postoperative follow-up time-points were: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 17, 30, 60, 90, 120, 150, 180 days. The surgery was done with application of two different grafts (Mucograft-xenograft and connective tissue graft-autologous). The differences in postoperative blood flow changes were compared between the two graft-groups.

次要结局

  • Postoperative wound fluid changes of the oral mucosa(6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Vag Janos

associate professor

Semmelweis University

研究点 (1)

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