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CTRI Number  CTRI/2024/07/069944 [Registered on: 04/07/2024] Trial Registered Prospectively
Last Modified On: 07/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of immediate temporomandibular joint clenching on pelvic tilt and length of hamstring muscle in normal individuals using PALM and sit and reach – A cross-sectional study 
Scientific Title of Study   Influence of acute temporomandibular joint clenching on pelvic tilt and hamstring length in normal individuals - A cross-sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  SAUMYA SRIVASTAVA 
Designation  ASSOCIATE PROFFESSOR 
Affiliation  Nitte Institute of Physiotherapy Nitte Deemed to be University 
Address  Department of Physiotherapy Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru
Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@yahoo.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  SAUMYA SRIVASTAVA 
Designation  ASSOCIATE PROFFESSOR 
Affiliation  Nitte Institute of Physiotherapy Nitte Deemed to be University 
Address  Department of Physiotherapy Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru
Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@yahoo.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  SAUMYA SRIVASTAVA 
Designation  ASSOCIATE PROFFESSOR 
Affiliation  Nitte Institute of Physiotherapy Nitte Deemed to be University 
Address  Department of Physiotherapy Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru
Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9740244077  
Fax    
Email  saumyasri2000@yahoo.com  
 
Source of Monetary or Material Support  
Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru 575018 
 
Primary Sponsor  
Name  Nitte Institute of Physiotherapy  
Address  Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru 575018 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Saumya Srivastava   NITTE INSTITUTE OF PHYSIOTHERAPY  First floor, Research department, Nitte Institute of Physiotherapy Nitte Deemed to be University, Nithyanandha nagar Deralakatte Manguluru. 575018
Dakshina Kannada
KARNATAKA 		 9740244077

saumyasri2000@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NO CONDITIONS  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  healthy induviduals 
 
ExclusionCriteria 
Details  1.Low back pain
2. TMJ issues
3. Psychological conditions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pelvic tilt was assessed with participants standing, using PALM calipers placed on marks slightly inferior to the ASIS and PSIS. Measurements were taken before and after the participants clenched their jaws for 10 seconds. Hamstring muscle length was assessed with the sit and reach test, where participants sat with legs extended and pressed a box against their feet, reaching forward along a measuring line. This test was also repeated with a 10-second jaw clench, and all values were recorded.   only once at base line 
 
Secondary Outcome  
Outcome  TimePoints 
waist circumfrence  only once at baseline 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/07/2024 
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="0"
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  

there is a dearth of literature determining the impact of acute clenching of TMJ on pelvic tilt and hamstrings length in normal individuals. Thus, the aim of the study is to determine whether there is any influence of acute TMJ clenching on pelvic tilt and hamstrings length the acute role of TMJ clenching on pelvic tilt. Also, the acute physiological relationship with TMJ clenching on pelvic tilt is unknown. There is also a need to explore the impact of TMJ clenching at functional muscle-length relationship on hamstrings.

 
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