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CTRI Number  CTRI/2020/09/027646 [Registered on: 08/09/2020] Trial Registered Prospectively
Last Modified On: 08/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparing tone of two muscles of face in patients with jaw pain before and after electric treatment. 
Scientific Title of Study   “A comparative study to assess muscle activity in symptomatic temporomandibular disorder patients by using Electromyography before and after ttreatment with Trans- cutaneous electrical nerve stimulation.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DASAM SRIMALLIKA 
Designation  POST GRADUATE STUDENT 
Affiliation  Vishnu dental college 
Address  Vishnu dental college vishnupur Bhimavaram West godavari district 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9989344094  
Fax  08816250894  
Email  kiranmalli2224@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRRAMESH TATAPUDI 
Designation  PROFESSOR 
Affiliation  Vishnu dental college 
Address  Vishnudental college vishnupur Bhimavaram,West godavari district 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9440847997  
Fax  08816250894  
Email  drramesht@gmail.com  
 
Details of Contact Person
Public Query  
Name  DRRAMESH TATAPUDI 
Designation  PROFESSOR 
Affiliation  Vishnu dental college 
Address  Vishnudental college vishnupur Bhimavaram,West godavari district 534202

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9440847997  
Fax  08816250894  
Email  drramesht@gmail.com  
 
Source of Monetary or Material Support  
BIOPAK ELECTROMYOGRAPHY . department of prosthodontics 
 
Primary Sponsor  
Name  VISHNU DENTAL COLLEGE 
Address  VISHNU DENTAL COLLEGE VISHNUPUR BHIMVARAM 
Type of Sponsor  Research institution and hospital 
 
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 
DSRIMALLIKA  VISHNU DENTAL COLLEGE  VISHNU DENTAL COLLEGE VISHNUPUR,ROOM NO 1,DEPARTMENT OF ORAL MEDICINE BHIMAVARAM
West Godavari
ANDHRA PRADESH 		 9989344094
08816250894
kiranmalli2224@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vishnu Institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Electromyography  The surface EMG record was obtained using BIOEMG III model, high EMG signal representation across all channels(2000 second per channel ),rejection ratio of 130Db at 60Hz.Before and after TENS. 
Intervention  Transcutaneous Electrical Nerve Stimulation  1.Device measuring 23× 64× 91mm and weighing 130 g with 9V battery 2. Dual Chambered with adjustable pulse amplitude (0-80 mA.) 3.Pulse rate (2Hz -120Hz) and pulse width (40µs-260µs) 4. Voltage 0-110 Volts maximum and maximum charge per pulse is 21. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Patients with an age group of 18 -45 years will be included.
2. Patients presenting with the tenderness of masticatory muscles in temporomandibular disorders.
 
 
ExclusionCriteria 
Details  1. Patients with systemic diseases such as arthritis / arthrosis.
2. History of patients using analgesics, muscle relaxants, anti-inflammatory drugs for the last 1 month.
3. History of tumors/surgery near temporomandibular joint region
4. History of patients with orthodontic treatment, facial trauma, dental anomalies.
5.patients with parafunctional habits
6. Pregnant patients.
7. Patients who have an internal implantable defibrillators and devices like pacemakers.
8. Patients with neurological disorders.
9. Patients not willing to give informed consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Muscle activity of masseter and
2.Muscle activity of anterior temporalis in symptomatic temporomandibular disorder patients before and after TENS
3.Muscle activity of masseter And Anterior temporalis at resting and clenching positions by EMG values.
 		 .Muscle activity of masseter -0 day
2.Muscle activity of anterior temporalis in symptomatic temporomandibular disorder patients before and after TENS-0 day
3.Muscle activity of masseter And Anterior temporalis at resting and clenching positions by EMG values.-0 day
 
 
Secondary Outcome  
Outcome  TimePoints 
VISUAL ANALOGUE SCORE SCALE BEFORE AND AFTER TENS THERAPY  VISUAL ANALOGUE SCORE SCALE BEFORE AND AFTER TENS THERAPY-O DAY 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   27/09/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    This is the study to compare muscle activity of masseter and anterior temporalis during rest and chewing positions before and after TENS application by using Electromyography. so the primary objective is  1. Muscle activity of masseter and anterior temporalis in symptomatic temporomandibular disorder patients before and after TENS, at resting and clenching positions by EMG values and the secondary objective is VAS scores for muscle pain. 
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