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临床试验/NCT06281873
NCT06281873已完成不适用

Outpatient Clinic of Alexandria University Teaching Hospital, Egypt

Alexandria University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2023年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Evaluation of the soft tissue wound's healing

研究概览

简要总结

the study evaluated the one stage endoscopic middle meatal antrostomy (EMMA) technique with the application of a platelet rich fibrin membrane (PRF) for Oroantral Fistula (OAF) closure and relief of maxillary sinusitis.

详细描述

This study was conducted on nine eligible patients who complained of OAF with odontogenic sinusitis. Oral fistulectomy was done with proper curettage. Then, EMMA was performed with simultaneous closure of the OAF by application of PRF membrane and covering it with an acrylic splint. Patients were clinically evaluated for closure of the OAF after 14th days postoperatively, relief of the symptoms, and assessment of the pain level. Also, measurement of the size of the bone defect with the aid of computed tomography (CT) preoperatively and 24th weeks postoperatively.

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
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 1 - Adult patients between the ages of 20-60 years. 2- Patients who were suffering from chronic fistula that occurred after the extraction of upper posterior teeth

排除标准

  • patients who have any systemic disease that contraindicates any intervention under general anesthesia (e.g., coronary artery disease).
  • OAF that occurred as a result of other causes (e.g., cyst,and trauma)

研究组 & 干预措施

closure of the OAF with PRF application

Experimental

This study was conducted on 9 patients. application of PRF membrane

干预措施: closure by PRF membrane (Procedure)

结局指标

主要结局

Evaluation of the soft tissue wound's healing

时间窗: 1st, 7th, and14 days postoperatively

closure of the fistula using the Clinical Healing Score (CHS). CHS: score ranging from 0-5

次要结局

  • Secondary radiographic outcomes, assessment of bone formation(24 weeks postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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