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Clinical Trials/CTRI/2026/01/100765
CTRI/2026/01/100765Not yet recruitingNot Applicable

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 site in 1 country242 target enrollmentStarted: January 19, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
242
Locations
1
Primary Endpoint
Association between presence of risk factors (systemic, stomatognathic, psychological and parafunctional) and temporomandibular disorders diagnosed using DC/TMD Axis I and II criteria.

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: At baseline (single visit) at the time of enrolment

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Saee Deshpande
Sponsor Class
Other [Primary Investigator herself]
Responsible Party
Principal Investigator
Principal Investigator

Dr Saee Deshpande

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

Study Sites (1)

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