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临床试验/NCT04967963
NCT04967963已完成不适用

Surgical Management of Stage-2 Medication-Related Osteonecrosis of the Jaw With Transplantation of Human Amniotic Membrane

Trakya University2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
Change in mucosal coverage

研究概览

简要总结

Medication-related osteonecrosis of the jaw (MRONJ) is a drug adverse reaction and there is no consensus for the treatment of MRONJ. The aim of this study is to evaluate the mucosal coverage using HAM after sequestrectomy in patients with stage-2 MRONJ.

详细描述

Medication-related osteonecrosis of the jaw (MRONJ) is a drug adverse reaction and a potentially serious complication. MRONJ is defined as the presence of exposed bone with intraoral or extraoral fistula in the maxillofacial region that does not heal for at least 8 weeks, seen in patients receiving antiresorptive or antiangiogenic agents but without a history of head and neck radiotherapy. Several treatment strategies have been recommended according to the stage of MRONJ, ranging from pharmacological conservative management to aggressive surgical approaches. According to the American Association of Oral and Maxillofacial Surgeons (AAOMS) position paper updated in 2014, conservative treatment for stage 0 and 1, minimally invasive surgical treatment for stage-2, and radical surgical treatment for stage-3 have been recommended. Furthermore, there is no consensus for the treatment of MRONJ.

The innermost membrane of the placenta; the human amniotic membrane (HAM), is an avascular membrane consisting of 5 layers: epithelium, basement membrane, compact layer, fibroblast layer, and spongy layer. HAM was used in many animal and human studies in the field of oral and maxillofacial surgery; for guided tissue regeneration, vestibuloplasty, temporomandibular joint surgery, closure of oroantral communication/fistula, periodontal surgery, oral mucosal defects, periapical endodontic surgery, cleft palate, and MRONJ.

The aim of this study is to provide mucosal coverage using HAM after sequestrectomy in patients with stage-2 MRONJ. In this case series, results of surgical treatment with HAM transplantation in 5 MRONJ cases were reported.

All donors were selected from volunteers undergoing elective cesarean section at Trakya University, Faculty of Medicine, Department of Obstetrics and Gynecology. Cryopreserved HAM was prepared as described previously by Kar et al. After preoperative clinical and radiographic evaluations, 14 MRONJ cases with stage-2 diagnosis were treated with HAM transplantation. Preoperative pain was evaluated by Visual Analogue Scale (VAS) from "0" (as no pain) to "10" (as the most severe pain experienced).

Before surgery, patients were treated with combined oral antibiotics (amoxicillin/clavulanic acid 1,000 mg + metronidazole 500 mg), oral analgesics (dexketoprofen 25 mg) and, antimicrobial mouth rinse (0.2% chlorhexidine digluconate) for 3 weeks. Surgical treatment was performed in patients who still had an infection (pain, erythema, or purulent discharge) and pain despite the medical treatment.

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

入选标准

  • For Donors:
  • Free of infections such as HIV, hepatitis B and C, and syphilis before and 6 months after the cesarean section
  • Volunteers over the age of 18
  • For Recipients:
  • Medication-related osteonecrosis of the jaw cases with stage-2 diagnosis

排除标准

  • For Donors:
  • Any infection described above.
  • Mentally retarded individuals
  • For Recipients:
  • MRONJ cases with stage-1, and stage-3 diagnosis
  • Mentally retarded individuals

结局指标

主要结局

Change in mucosal coverage

时间窗: 12 weeks

Mucosal coverage will be evaluated as "+++" for complete mucosal coverage, "++" for \>50% of mucosal coverage, "+" for \<50% of mucosal coverage, "-" for no improvement.

次要结局

  • Change in Pain(12 weeks)
  • Change in suppuration and erythema as signs of infection(12 weeks)

研究者

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

Fatma Gülfeşan Çanakçi

Assistant Professor

Trakya University

研究点 (2)

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