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临床试验/CTRI/2026/01/100765
CTRI/2026/01/100765尚未招募不适用

ASSESSMENT OF RISK FACTORS AND THEIR ASSOCIATION WITH CLINICAL MANIFESTATIONS AND ORAL HEALTH RELATED QUALITY OF LIFE IN PATIENTS WITH TEMPORO-MANDIBULAR DISORDERS IN INDIAN POPULATION: A CASE-CONTROL STUDY

Dr Saee Deshpande1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2026年1月19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
242
试验地点
1
主要终点
Association between presence of risk factors (systemic, stomatognathic, psychological and parafunctional) and temporomandibular disorders diagnosed using DC/TMD Axis I and II criteria.

研究概览

简要总结

Temporomandibular disorders (TMDs) are multifactorial conditions affecting the temporomandibular joint and masticatory muscles and are a common cause of chronic orofacial pain. Various systemic, psychological and stomatognathic risk factors have been implicated in the development of TMD; however, their association with clinical manifestations and oral health related quality of life in the Indian population remains inadequately explored.

This observational analytical case–control study aims to assess the association between different risk factors, clinical manifestations and oral health related quality of life in patients with temporomandibular disorders diagnosed using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I and II. A total of 242 participants will be recruited, comprising 121 cases with TMD and 121 age- and gender-matched controls without TMD.

Data will be collected using validated questionnaires and standardized clinical examination, including DC/TMD instruments, tooth attrition assessment and OHIP-TMD questionnaire. All outcomes will be assessed at baseline. The findings of this study are expected to provide insights into the risk factors and their impact on quality of life in TMD patients, which may help in better understanding, prevention and management of temporomandibular disorders in the Indian population.

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

  • Case Group Patients diagnosed with Temporomandibular Disorders according to DC TMD Axis I and Axis II criteria Male and female patients aged 18 to 65 years Patients reporting to the Department of Prosthodontics and Crown & Bridge Patients willing to participate and provide written informed consent Control Group Age and gender-matched individuals without signs or symptoms of TMD Patients reporting to the dental hospital for reasons other than TMD Male and female patients aged 18 to 65 years Willing to participate and provide written informed consent.

排除标准

  • Subjects unwilling or unable to provide informed consent History of malignancy in the head and neck region History of major orofacial surgery Patients who have undergone cervicofacial chemotherapy or radiotherapy Patients with recent facial trauma or fractures involving the jaws Patients currently under treatment for acute infections or inflammatory conditions affecting the temporomandibular joint.

结局指标

主要结局

Association between presence of risk factors (systemic, stomatognathic, psychological and parafunctional) and temporomandibular disorders diagnosed using DC/TMD Axis I and II criteria.

时间窗: At baseline (single visit) at the time of enrolment

次要结局

未报告次要终点

研究者

发起方
Dr Saee Deshpande
申办方类型
Other [Primary Investigator herself]
责任方
Principal Investigator
主要研究者

Dr Saee Deshpande

VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road

研究点 (1)

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