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临床试验/CTRI/2024/04/065547
CTRI/2024/04/065547尚未招募4 期

Assessment of the Temporomandibular Joint Health, Occlusal Load Distribution and Masticatory Function in patients with Unilateral Cleft Lip and Palate following Orthodontic Treatment : A Prospective Study

Dr Minakshi Tibrewal1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年4月30日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
14
试验地点
1
主要终点
Temporomandibular Joint

研究概览

简要总结

In this study, patients with Unilateral Cleft Lip and Palate will be evaluated for temporomandibular joint health using Joint Vibrational Analysis(JVA), Occlusal load Distribution using T-Scan, Masticatory function using Electromyography and Masticatory Efficiency using colorimetric method before orthodontic treatment and after orthodontic treatment . Changes  in the temporomandibular joint health, occlusal load distribution, masticatory function and masticatory efficiency will be compared before and after orthodontic treatment.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
14.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Repaired unilateral cleft lip and palate patients with GOSLON Yardstick group 1, 2 and
  • Age group between 14-30 years Systemically healthy patients.

排除标准

  • Syndromic unilateral cleft lip and patients.
  • Patients with bilateral cleft lip and palate.
  • Patients requiring orthognathic surgery.
  • Patients with signs or symptoms of myofascial disorders causing discomfort or pain of the masticatory musculature.

结局指标

主要结局

Temporomandibular Joint

时间窗: T0 before fixed orthodontic treatment - At baseline | T1 after fixed orthodontic treatment - After 18 months

sounds, Amplitude peak

时间窗: T0 before fixed orthodontic treatment - At baseline | T1 after fixed orthodontic treatment - After 18 months

(pascals) and Frequency peak

时间窗: T0 before fixed orthodontic treatment - At baseline | T1 after fixed orthodontic treatment - After 18 months

(Hertz), Bite force(occlusal load), Electrical activity of masseter

时间窗: T0 before fixed orthodontic treatment - At baseline | T1 after fixed orthodontic treatment - After 18 months

and anterior temporalis muscle

时间窗: T0 before fixed orthodontic treatment - At baseline | T1 after fixed orthodontic treatment - After 18 months

at rest and maximum voluntary

时间窗: T0 before fixed orthodontic treatment - At baseline | T1 after fixed orthodontic treatment - After 18 months

clenching(µV/µV%)

时间窗: T0 before fixed orthodontic treatment - At baseline | T1 after fixed orthodontic treatment - After 18 months

次要结局

  • Temporomandibular Joint Disorder & masticatory efficiency(Molar extinction coefficient(ε)(per gram of carrot))

研究者

发起方
Dr Minakshi Tibrewal
申办方类型
Other [self-funded]
责任方
Principal Investigator
主要研究者

Dr Minakshi Tibrewal

Manav Rachna Dental College

研究点 (1)

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