跳至主要内容
临床试验/NCT04800250
NCT04800250终止不适用

Mucogain Matrix Versus Connective Tissue Graft: "MUCOGREFFE Project"

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2023年7月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
2
主要终点
Mean root coverage obtained with both techniques

研究概览

简要总结

Limitation of donor site and significant postoperative morbidity are often described in connective tissue graft. We want to show if mucogain matrix used in tunnel technique to recover RTI Cairo recessions defects could be an alternative to connective tissue graft

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Patient with 3 contiguous, symmetrical and bilateral RTI Cairo gingival recessions (Miller Class 1) (i.e. 6 recessions)
  • Patient non-smoker
  • Patient affiliated to social security
  • Patient signed informed consent.

排除标准

  • Patient with or having presented an acute or chronic severe cardiovascular, kidney, liver, gastrointestinal, allergic, endocrine, neuropsychiatric pathology, developed cancer of the upper aero digestive tract treated with radiotherapy
  • Patient with severe hemorrhinopathy
  • Patient treated with oral retinoids, bisphosphonates, oral or anticonvulsants
  • Patient who has taken steroidal or non-steroidal anti-inflammatory therapy, anti-cancer or immunosuppressive chemotherapy within the last 6 months.
  • Patient with contraindication to necessary and pre-, per- or post-operative treatments
  • Follow-up of the patient seemed difficult by the investigator
  • Patient with insufficient oral hygiene incompatible with oral surgery

研究组 & 干预措施

A - Mucogain matrix on right

Experimental

The patient will receive mucogain matrix on right side and connective tissue graft on left side.

干预措施: Treatment of gingival recessions (Procedure)

B - Mucogain matrix on left

Experimental

The patient will receive mucogain matrix on left side and connective tissue graft on right side.

干预措施: Treatment of gingival recessions (Procedure)

结局指标

主要结局

Mean root coverage obtained with both techniques

时间窗: 6 months

To compare the mean root coverage obtained with the Creos® Mucogain matrix and connective tissue graft in the treatment of Cairo RT1 class maxillary recessions (Miller Class 1).

次要结局

  • Postoperative complications with both techniques(10 days)
  • Postoperative pain with both techniques(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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