FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093669 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The combination of physiotherapy intervention and splint therapy in temporomandibular joint pain. 
Scientific Title of Study   The effect of deep transverse friction massage and splint therapy on pain, range of motion, quality of life, and disability in Temporomandibular joint dysfunction - A comparative study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shashank Kumar 
Designation  Ph.D research scholar 
Affiliation  Sardar Bhagwan Singh University 
Address  Research lab, Department of Physiotherapy, campus-2, Sardar Bhagwan Singh University, Balawala, Dehradun.
Department of Physiotherapy, First Floor, Uttaranchal College of Health Sciences, Uttarancha University, Prem Nagar, Dehradun.
Dehradun
UTTARANCHAL
248001
India 
Phone  8273079260  
Fax    
Email  shashankkumar67@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  shashank kumar 
Designation  Ph.D research scholar 
Affiliation  sardar Bhagwan Singh University 
Address  Department of Physiotherapy, campus-2, Sardar Bhagwan Singh University, Balawala, Dehradun.
Department of Physiotherapy, first floor, Uttaranchal College of Health Science-Uttaranchal University, prem nagar, Dehradun.
Dehradun
UTTARANCHAL
248001
India 
Phone  8273079260  
Fax    
Email  shashankkumar67@gmail.com  
 
Details of Contact Person
Public Query  
Name  shashank kumar 
Designation  Ph.D research scholar 
Affiliation  sardar Bhagwan Singh University 
Address  Department of Physiotherapy, campus-2, Sardar Bhagwan Singh University, Balawala, Dehradun.
Department of Physiotherapy, first floor, Uttaranchal College of Health Science-Uttaranchal University, prem nagar, Dehradun.
Dehradun
UTTARANCHAL
248001
India 
Phone  8273079260  
Fax    
Email  shashankkumar67@gmail.com  
 
Source of Monetary or Material Support  
Physiotherapy Outpatient Department, campus-2, Sardar Bhagwan Singh University Balawala Dehradun. 
 
Primary Sponsor  
Name  self funded 
Address  Department of Physiotherapy, campus-2, Sardar Bhagwan Singh University, Balawala Dehradun, India.  
Type of Sponsor  Research institution 
 
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 
Dr R Arunmozhi  Physiotherapy OPDs, Campus 2, Sardar Bhagwan Singh University  Department of Physiotherapy, Campus-2, Sardar Bhagwan Singh University, Balawala, Dehradun
Dehradun
UTTARANCHAL 		 7895617031

rmozhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board, sardar bhagwan singh university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Temporomandibular joint dysfunction 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  experimental group A  Deep transverse friction, Therapeutic Ultrasound and stretching Exercises. 3 sessions Per week for 6 weeks and total for 25 minutes. 
Comparator Agent  experimental group B  Occlusion splint for six weeks, therapeutic ultrasound (10 minutes) and stretching (5 minutes) three sessions per week for six weeks. 
Comparator Agent  experimental group C  combination of Splint therapy for six weeks, deep transverse friction, therapeutic ultrasound, and stretching exercises. 3 sessions per week for 6 weeks and a total duration of 25 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Myogenic TMD including masticatory muscle spasm.
History of peri-auricular pain with or without joint sounds of at least 3 months in duration.
Referred Patients from a dentist with the diagnosis of TMJ dysfunction
 
 
ExclusionCriteria 
Details  TMD with structural changes in the TMJ due to known arthritis
Known Rheumatoid Disease.
Diagnosed Ankylosing Spondylitis, Disc Degeneration or Bell’s palsy
History of malignancy in the last 5 years,
Other physical contraindications such as, fracture, dislocations, Known Metabolic diseases (such as Cushing disease, gout),
Known Hematologic disorders (such as anemia or leukemia)
Patients could not have symptoms arising from active pathology of the head, face, and jaw
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numerical Pain Rating Scale for pain  first week, third week and six week 
 
Secondary Outcome  
Outcome  TimePoints 
DIGITAL VERNIER CALIPER for Joint restriction, Jaw Functional Limitation Scale for Joint restriction, Oral Health Impact Profile-14 for Quality of life.  first week, third week & six week. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   06/09/2025 
Date of Study Completion (India) 08/12/2025 
Date of First Enrollment (Global)  06/09/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 dysfunction is a disorder involving masticatory muscles, temporomandibular joints, and adjacent segments. These disturbances affect the dynamic stability of the structures, leading to a series of signs and symptoms typical of this dysfunction . The temporomandibular joint (TMJ) consists of two synovial joints that work together. However, this unique trait presents certain problems, and the treatment of these issues is often complex. The common signs and symptoms of TMD include pain, joint sounds (clicking, grating), limited or asymmetrical jaw movement, and spasms of the chewing muscles. These symptoms can profoundly affect health and quality of life. An increasing number of cases have complained of uneasiness in the jaw due to changes in living style, and eating behavior, as well as decreasing exercises and improving the number of several aetiologies for degenerative diseases. 
Close