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临床试验/NCT02206009
NCT02206009已完成1 期

PriMatrix Dermal Repair Scaffold Utilization Intraorally

Lauren M. F. Syrowik1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
8
试验地点
1
主要终点
Change in depth of keratinized tissue

研究概览

简要总结

Is PriMatrix wound dressing capable of regenerating gum tissue inside the mouth?

详细描述

PriMatrix is an acellular fetal bovine dermal matrix that has a wide array of FDA approved uses. These uses include partial- and full-thickness wounds, pressure, diabetic, and venous ulcers, surgical wounds, trauma wounds, tunneled wounds, and draining wounds. It is a sheet-like matrix made up primarily of type I and type III collagen. An increased proportion of type III collagen appears to play a key role in healing and regeneration.

The use of extracellular dermal matrices is a relatively young field, and the exact mechanism by which PriMatrix promotes skin regeneration is still unknown. Despite this, PriMatrix has demonstrated differences in manufacturing and molecular composition that make it conducive to the harsh environments in which it has already been tested. Intraorally, where there is a rich vascular bed, this material holds exceeding promise.

Utilizing this vascularity, autogenous free gingival grafts from the palate have already had their efficacy proven as a method of augmenting the keratinized tissue.The need to increase the keratinized tissue is based upon the postulation that less mobile, keratinized epithelium is more resilient than the non-keratinized oral mucosa. This is especially important in areas where recession and attachment loss has already occurred. Without having keratinized gingiva apical to the recession area, it has been suggested that there is a greater risk for more attachment loss to occur, thus reducing the support for the tooth. In addition, autogenous free gingival grafts have demonstrated the phenomenon of "creeping attachment" where a portion of the recession actually becomes covered as a result of grafting.

While autogenous grafting is the gold standard in soft tissue augmentation, the amount of tissue that can be taken from the palate is limited, making it difficult to treat patients with generalized recession. Furthermore, a secondary surgical site increases the morbidity associated with the procedure. The hypothesis of this study is that PriMatrix will be able to provide similar results to an autogenous free gingival graft.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Must have one to three consecutive teeth with recession and less than 1 mm of keratinized gingiva

排除标准

  • •Pregnancy
  • •Uncontrolled diabetes
  • •Use of continuous positive airway pressure (CPAP) machine for sleep apnea
  • •Oral appliances (removable partial dentures, braces, mandibular advancement, bruxism splints, etc.)
  • •Tobacco use
  • •Immunocompromised individual

研究组 & 干预措施

Collagen membrane

Experimental

First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.

干预措施: Collagen Membrane (Device)

结局指标

主要结局

Change in depth of keratinized tissue

时间窗: baseline, approximately 6 months after the procedure

The amount of gingival augmentation will be assessed by the depth of keratinized tissue, measured in millimeters. Change in the amount of keratinized tissue in the areas of interest from baseline to 6 months will be tested to see if they are statistically significant.

次要结局

未报告次要终点

研究者

发起方
Lauren M. F. Syrowik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lauren M. F. Syrowik

DDS

Mayo Clinic

研究点 (1)

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