| CTRI Number |
CTRI/2025/03/082109 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship of spinal curvature craniovertebral angle neck pain and skeletal divergence in Temporomandibular Joint Disorders |
|
Scientific Title of Study
|
Correlation of spinal curvature craniovertebral angle neck pain and skeletal divergence to Temporomandibular Joint Disorders A Casecontrol Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MAMTA SINGH |
| Designation |
Post garduate student |
| Affiliation |
ITS dental college hospital and research centre |
| Address |
Department of Oral Medicine and Radiology,ITS Dental college hospital and research centre, 47 Knowledge park, 3 Greater Noida
47 Knowledge park 3 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9910467389 |
| Fax |
|
| Email |
mamta.mds24@its.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MANISHA LAKHANPAL SHARMA |
| Designation |
Professor and head of the department |
| Affiliation |
ITS dental college hospital and research centre |
| Address |
Department of Oral Medicine and Radiology ITS Dental college and research centre 47 Knowledge park 3 Greater Noida
47 Knowledge park 3 Greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9871112620 |
| Fax |
|
| Email |
hod.om.gn@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
MAMTA SINGH |
| Designation |
Post garduate student |
| Affiliation |
ITS dental college hospital and research centre |
| Address |
Department of Oral Medicine and Radiology,ITS dental college and research centre,47 knowledge park ,Greater noida
47 Knowledge park 3 Greater noida
Gautam Buddha Nagar
UTTAR PRADESH
201308
India |
| Phone |
9910467389 |
| Fax |
|
| Email |
mamta.mds24@its.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Oral Medicine and Radiology,ITS dental college hospital and research centre,47 knowledge park ,greater noida,gautam budh nagar,uttar pradesh ,india 201308 |
|
|
Primary Sponsor
|
| Name |
ITS dental college hospital and research centre |
| Address |
47 Knowledge park 3 greater noida 201308,gautam budh nagar ,uttar pradesh, india |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MANISHA LAKHANPAL SHARMA |
ITS dental college hospital and research centre 47 Knowledge park 3 Greater noida 201308,gautam budh nagar ,uttar pradesh ,india |
|
|
Countries of Recruitment
|
Oman |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR MAMTA SINGH |
ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Department of Oral Medicine and Radiology,ITS dental college hospital and research centre,47 knowledge park,greater noida
Gautam Buddha Nagar
UTTAR PRADESH |
9910467389
mamta.mds24@its.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ITS DENTAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to be a part of study.
Patients with TMD.
Healthy patients without TMD as a
control. |
|
| ExclusionCriteria |
| Details |
Patients unwilling to be a part of this
study.
Patients who have had trauma associated
with TMJ disorders.
Patients with any history of surgery
associated with TMJ.
Patients with pregnancy
Developmental TMJ anomalies and
congenital malformations. Patients with history of any neuromuscular
disorders.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Spinal curvature, craniovertebral angle, neck pain and skeletal divergence a contributing
factor to the etiology of Temporomandibular Joint Disorders |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Spinal curvature, craniovertebral angle, neck pain and skeletal divergence a contributing
factor to the etiology of Temporomandibular Joint Disorders |
2 YEARS |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To assess the spinal curvature, craniovertebral angle, neck pain and skeletal divergence as an etiology of Temporomandibular Joint Disorders.Assessment of cervical spine curvature using flexicurve ruler and assessment of craniovertebral angle using goniometer.Assessment of neck pain using Northwick Park pain Questionnaire.Assessment of temporomandibular joint disorders using Fonseca’ Questionnaire.Assessment of skeletal divergence using lateral cephalogram.Correlation of cervical spine curvature, craniovertebral angle, neck pain, skeletal divergence to Temporomandibular joint disorders.creteria of inclusion and exclusion will be followed.the possibility of TMD in subjects with altered spinal Curvature, craniovertebral angle, neck pain and skeletal divergence has yet to be completely explored and still not documented with all these etiological factors. The correlation shall help in establishing an etiology and designing a holistic treatment plan leading to the alignment of the entire craniovetebral complex. |