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临床试验/NCT06694532
NCT06694532招募中1 期

Comparative Study Between the Effectiveness of High Versus Low Molecular Weight Hyaluronic Acid in TMJ Arthrocentesis

Basel khaled mohamed1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis

研究概览

简要总结

The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment.

详细描述

The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder.

, 1- significantly improving the pain on scale 1-10 , and 2-significant improvements in mouth opening range in mm by the distance between the edges of the frontal incisors with a ruler or caliper and joint noise.

3-The presence of absence of clicking and cracking in jaw .

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
Single (Care Provider)

盲法说明

The study will be carried out in Patients in two Groups aged between 17 to 70 years , of both sexes, who had painful symptoms, with or without presence of joint noise, and had unilateral or bilateral internal derangement of the TMJ proven by clinical examination, with no improvement after conservative treatment, were included in the study.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pain or tenderness of the jaw
  • Pain in one or both of the temporomandibular joints
  • Aching pain in and around your ear
  • Difficulty chewing or pain while chewing
  • Aching facial pain
  • Locking of the joint,

排除标准

  • Muscular TMJ disorders
  • Bleeding tendency

研究组 & 干预措施

low molcular weight hyaurinic acid

Experimental

patients injected with low molucular weight hyalurinic acid .

干预措施: Syringes (Device)

high molucular weight hyalurinic acid .

Experimental

patients injected e high molucular weight hyalurinic acid .

干预措施: Hyaluronic acid (Drug)

high molucular weight hyalurinic acid .

Experimental

patients injected e high molucular weight hyalurinic acid .

干预措施: Syringes (Device)

low molcular weight hyaurinic acid

Experimental

patients injected with low molucular weight hyalurinic acid .

干预措施: Hyaluronic acid (Drug)

结局指标

主要结局

EFFICACY between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis

时间窗: 36 months

The MEASUREMENT TOOL of the study will be carried out by 2 groups the first will be injected by high molecular weight hyaluronic acid and the second wil be injected by low molecular weight hyaluronic acid Then compare between Efectevness of injection of high-molecular weight versus Low moecular weight hyaluronic acid after two-needle arthrocentesis in improving the signs and symptoms of intra-articular TMJ disorder. , 1- significantly improving the pain on scale 1-10 , and

次要结局

  • comparative between injection of high versus low molecular weight hyaluronic acid in TMJ arthrocentesis(36 months)

研究者

发起方
Basel khaled mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Basel khaled mohamed

Assistant Lecturer

Assiut University

研究点 (1)

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