| CTRI Number |
CTRI/2026/01/100765 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk factors for Temporomandibular disorders |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saee Deshpande |
| Designation |
Professor |
| Affiliation |
VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road |
| Address |
Room No 205, Dept.of Prosthodontics, VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road
Room No 205, Dept.of Prosthodontics, VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09823794366 |
| Fax |
|
| Email |
drsaeedeshpande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Abhay Pande |
| Designation |
HOD Professor and Phd Guide |
| Affiliation |
VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road |
| Address |
Room No 205, Dept.of Prosthodontics, VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road
Room No 205, Dept.of Prosthodontics, VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822931899 |
| Fax |
|
| Email |
neelampande112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saee Deshpande |
| Designation |
Professor |
| Affiliation |
VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road |
| Address |
Room No 205, Dept.of Prosthodontics, VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road
Room No 205, Dept.of Prosthodontics, VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09823794366 |
| Fax |
|
| Email |
drsaeedeshpande@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Saee Deshpande |
| Address |
205- Dept of Prosthodontics, VSPMDCRC,Nagpur |
| Type of Sponsor |
Other [Primary Investigator herself] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Saee Deshpande |
VSPMs Dental College |
Department of Prosthodontics Room no 205 VSPMs Dental College,Digdoh Hills, CRPF Gate, Hingna Road-440019
Nagpur
MAHARASHTRA |
09823794366
drsaeedeshmukh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
as controls |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between presence of risk factors (systemic, stomatognathic, psychological and parafunctional) and temporomandibular disorders diagnosed using DC/TMD Axis I and II criteria. |
At baseline (single visit) at the time of enrolment |
|
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Secondary Outcome
|
|
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Target Sample Size
|
Total Sample Size="242"
Sample Size from India="242"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |