跳至主要内容
临床试验/NCT07177378
NCT07177378Enrolling By Invitation不适用

Management of Medication Related Osteonecrosis of the Jaws Using Piezosurgery With Simultaneous Double Periosteal Flap Closure

Tanta University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月3日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
20
试验地点
2
主要终点
evaluation of pain

研究概览

简要总结

20 patients with MRONJ underwent surgical debridement using piezosurgery then closure using double periosteal flap

详细描述

20 patients with MRONJ underwent surgical debridement, crestal incision and oblique releasing incision were performed to expose the area of osteomyelitis, then squesterum was removed using piezosurgery. After complete debridement, the periosteal layer was dissected from mucoperiosteal buccal flap and based superiorly, then turn upward to be sutured to the lingual flap followed by suturing of buccal flap to achieve double layers closure

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

性别
All
接受健康志愿者

入选标准

  • patients with MRONJ

排除标准

  • Patients had a history of radiotherapy
  • Patients need only conservative treatment

研究组 & 干预措施

management of medication related osteonecrosis of the jaw

Experimental

The buccal mucoperiosteal flap was elevated to expose the area of osteonecrosis in the mandible. it was debrided using piezosurgery then closure was achieved using double periosteal flap

干预措施: management of medication related osteonecrosis of the jaw (Device)

结局指标

主要结局

evaluation of pain

时间窗: one month

visual analog scale (VAS), with 0 indicating no pain and 10 indicating the most severe pain.

wound healing

时间窗: one -3 months

the wound healing index (WHI) which scored soft tissue healing according to the following criteria: score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; and score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration

次要结局

未报告次要终点

研究者

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

mona samy sheta

lecturer of oral and maxillofacial surgery

Tanta University

研究点 (2)

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