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CTRI Number  CTRI/2024/08/072211 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two treatment modalities, Phonophoresis and Transcutaneous Electrical Nerve Stimulation therapy in patients with Temporomandibular Joint pain.  
Scientific Title of Study   A comparative study on efficacy of phonophoresis and transcutaneous electrical nerve stimulation therapy in temporomandibular joint pain - a randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  G Kalai Elamathy 
Designation  Postgraduate MDS 
Affiliation  Rajah Muthiah Dental College and Hospital 
Address  Department of Oral Medicine and Radiology Rajah Muthiah Dental College and Hospital Cuddalore District Annamalai nagar Chidambaram

Cuddalore
TAMIL NADU
608002
India 
Phone  9944970250  
Fax    
Email  kalaielamathy98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. S. Ramasamy 
Designation  Professor, Head Of the Department  
Affiliation  Rajah Muthiah Dental College and Hospital 
Address  Department of Oral Medicine and Radiology Rajah Muthiah Dental College and Hospital Cuddalore District Annamalai nagar Chidambaram

Cuddalore
TAMIL NADU
608002
India 
Phone  9443124179  
Fax    
Email  vgnsrs71@gmail.com  
 
Details of Contact Person
Public Query  
Name  G Kalai Elamathy 
Designation  Postgraduate MDS 
Affiliation  Rajah Muthiah Dental College and Hospital 
Address  Department of Oral Medicine and Radiology Rajah Muthiah Dental College and Hospital Cuddalore District Annamalai nagar Chidambaram

Cuddalore
TAMIL NADU
608002
India 
Phone  9944970250  
Fax    
Email  kalaielamathy98@gmail.com  
 
Source of Monetary or Material Support  
Government dental college and hospital, Cuddalore district (erstwhile rajah muthiah dental college and hospital), Annamalai nagar, Chidambaram - 608002. 
 
Primary Sponsor  
Name  G Kalai Elamathy 
Address  Rajah Muthiah Dental College and Hospital 
Type of Sponsor  Other [Self] 
 
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 G Kalai Elamathy  Rajah Muthiah Dental College and Hospital  Department of Oral Medicine and Radiology
Cuddalore
TAMIL NADU 		 9944970250

kalaielamathy98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee, Rajah muthiah medical college, Annamalai university, Annamalai nagar - 608002  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M266||Temporomandibular joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Phonophoresis   Ultrasound with aceclofenac gel 1.5% for 15 minutes, topical application (phonophoresis) - duration of 4 weeks 
Comparator Agent  Transcutaneous electrical nerve stimulation therapy  Transcutaneous electrical nerve stimulation machine: 10Hz for 15 minutes, using electrode pad (transcutaneous electrical nerve stimulation therapy) - duration of 4 weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  25 to 50 years of patients present with temporomandibular joint pain and dysfunction
 
 
ExclusionCriteria 
Details  1. Occlusal disturbances by restorative dental work
2. Presence of systemic diseases
3. History of recent trauma
4. Presence of a cardiac pacemaker or a serious/unstable heart condition
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Maximum mouth opening (active mouth opening and passive mouth opening)
2. Visual analogue scale
 		 1. Maximum mouth opening (active mouth opening and passive mouth opening): at baseline, 1st week, 2nd week, 3rd week, 4th week (weekly twice)
2. Visual analogue scale: at baseline, 1st week, 2nd week, 3rd week, 4th week (weekly twice)
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   20/08/2024 
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 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   This is a randomized, double blind, parallel group trial comparing the efficacy of Phonophoresis and Transcutaneous Electrical Nerve Stimulation therapy in 28 patients with temporomandibular joint pain that will be conducted in Government Dental College and Hospital, Cuddalore District. The primary outcome measures will be Maximum Mouth Opening (Active Mouth Opening and Passive Mouth Opening) and Visual Analog Scale (VAS) at 1 month.      
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