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临床试验/NCT05407493
NCT05407493Unknown不适用

Comparison of a Double-layered Technique With the Buccal Sliding Flap for Closure of Oroantral Communication

University of Siena1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Closure success

研究概览

简要总结

The aim of this study is to compare the clinical results of combining a pedicle connective palatal flap with a trapezoid buccal flap with the standard buccal flap alone in the closure of oro-antral fistula (OAF), and the buccal flap combined with leukocyte and platelet rich fibrin.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible population among those older than 18 y.o, systemically healthy, with a diagnosis of OAC (OroAntral Communication), or with a strong pre-extractive radiographic suspicion of potential OAC, and associated symptoms (varying among cheek pain with nasal obstruction, purulent rhinorrhea, foul odor, foul taste, headaches, anterior maxillary tenderness, and postnasal drip) .

排除标准

  • i) received antibiotic therapy in the last 3 months ii) requiring anticoagulation therapy iii) had systemic diseases that could interfere with oral tissue healing process/bleeding iv) were using bisphosfonates v) were pregnant vi) had mental/physical disabilities vii) underwent radiation treatment to the head or neck region.

结局指标

主要结局

Closure success

时间窗: One month after surgery

Measured with probing and Valsalva test

次要结局

  • Patient reported Pain(Each week for one month)

研究者

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

Nicola Discepoli

Prof

University of Siena

研究点 (1)

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