跳至主要内容
临床试验/CTRI/2025/09/094379
CTRI/2025/09/094379尚未招募不适用

Trismus prevalance, Health related Quality of life and management among patients treated for oral surgical procedures at a tertiary care hospital in coastal Karnataka

Prajna P Nayak1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年10月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
prevalence of trismus among patients

研究概览

简要总结

This prospective cross-sectional study will be conducted in all Patients being treated for oral surgical procedures that can have trismus as a potential complication at MCODS, Manipal between August 2024 to July 2025. Permission will be taken from the Institutional Ethical Committee before proceeding with the study. Informed consent will be collected from all enrolled patients prior to data collection.

A self-administered questionnaire will be given to each patient who is being treated for oral surgical procedures that can have trismus as a potential complication at MCODS, Manipal.

Details on socio-demographic characteristics on patient’s age, gender, tobacco use, tumor site, and treatment modalities (surgical treatment, radiation, chemotherapy) will be first collected from the patient. The questionnaire will also contain Gothenburg Trismus Questionnaire - 2 (GTQ 2) (Johansson M et al., 2020) and Visual Analogue Scale (Gaston-Johansson F., 1996).

Inter-incisal

distance will then be measured. Inter-incisal

distance will be measured using digital caliper in millimeters Trismus will be classified based on criteria as mild (31-35 mm), moderate (26-30 mm) and severe (< 25 mm) (Thomas et al., 1988) In edentulous patients, distance between alveolus ridge was measured Quality of lifo is measured using a calibrated Visual Analog Scale with a choice of 0-100, from worst imaginable health state to best imaginable health state.

Gothenburg Trismus Questionnaire - 2 (GTQ 2) contains questions related to mouth opening and trismus.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients being treated for oral surgical procedures that can have trismus as a potential complications and Patients aged between 18-65 years.

排除标准

  • Patients with pharyngeal cancers, exclusive lip cancers, and Unwilling patients.

结局指标

主要结局

prevalence of trismus among patients

时间窗: baseline - cross-sectional

次要结局

未报告次要终点

研究者

发起方
Prajna P Nayak
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Prajna P Nayak

Manipal College of Dental Sciences, Manipal

研究点 (1)

Loading locations...

相似试验