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临床试验/NCT04816253
NCT04816253已完成不适用

Methylprednisolone and Hyaluronic Acid Versus Each Agent Alone to Control Post-extraction Complications of Impacted Mandibular Third Molar

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle

研究概览

简要总结

Impacted mandibular 3rd molar will be extracted in all patients, then patients will be divided, according to material placed in extraction socket into 3 groups: control, hyaluronic acid and honey. Then post extraction complications will be evaluated

详细描述

Impacted Mandibular third molar will be extracted under local anesthesia Through standard surgical flap elevation, after extraction and wound irrigation a material facilitate healing will be placed. According to material will be placed patients will be divide into 3 group: control ( no material, second group hyaluronic acid, third group ( honey).. then wound will be closed. Postoperative pain ( through visual analog scale) , edema, total dose of analgesic, mandibular movement (interincisal distance in mm) will be evaluated preoperative, 1,2,3,7, and 10 day after extraction

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
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy patients
  • patient has impacted 3rd molar

排除标准

  • medically compromised patients Heavy smoking patients

研究组 & 干预措施

Normal saline

Placebo Comparator

Normal saline irrigation after extraction and No drug placed in tooth socket

干预措施: Normal saline (Drug)

Gengigel

Active Comparator

Gengigel (Hyaluronic acid) placed after extraction

干预措施: Hyaluronic acid (Drug)

Methylprednisolone

Active Comparator

Methylprednisolone will be given intravenous to a patient half an hour before the surgery

干预措施: Methylprednisolone (Drug)

Methylprednisolone and Gengigel

Active Comparator

Methylprednisolone will be given intravenous to a patient half an hour before the surgery and Gengigel (Hyaluronic acid) placed after extraction

干预措施: Methylprednisolone and Hyaluronic acid (Drug)

结局指标

主要结局

Size of edema will be assessed from finial angle and Travis of ear to mental ala of Nes and mouth angle

时间窗: 7th day postoperative

Edema measured from gonial angle and Tragus to mental, angle of mouth, ala of nose, and lateral canthus of eye respectively

Interincisal distance

时间窗: 7th day postoperative

Measuring distance between upper lower anterior teeth in mm

Total amount of analgesic

时间窗: 7th day postoperative

Total amount of analgesic Will be calculated

Assessment of pain using Visual analog scale

时间窗: 7th day

Patient asked to describe pain intensity subjectively on visual analog scale where 0 mean no pain while 10 mean sever pain

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

Alaa Altaweel

Associate professor

Al-Azhar University

研究点 (1)

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