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CTRI Number  CTRI/2025/09/094067 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [Low level laser therapy; Topical analgesic]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of combined laser and painkiller therapy with painkiller therapy alone in patients with muscle pain in jaw region. 
Scientific Title of Study   Comparative evaluation of Efficacy of Combination therapy(Low level laser therapy and topical analgesic) with topical analgesic therapy alone in patients with Myofascial pain dysfunction syndrome-A randomized controlled 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  Dr Rutuja Anil Jadhav 
Designation  Post-graduate student 
Affiliation  Bharati Vidyapeeth(Deemed to be University) Dental College and Hospital,Pune 
Address  Department of Oral Medicine and Radiology, Room No.14,Bharati Vidyapeeth(Deemed to be University) Dental College and hospital, Pune
Dhanakawadi-Katraj, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9403667463  
Fax    
Email  rutuja.jadhav1-dchpune@bvp.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Anil Mhapuskar 
Designation  Associate professor and head of the department 
Affiliation  Bharati Vidyapeeth(Deemed to be University) Dental College and Hospital,Pune 
Address  Department of Oral Medicine and Radiology, Room No.14, Bharati Vidyapeeth(Deemed to be University) Dental College and hospital, Pune
Dhanakawadi-Katraj, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9850285143  
Fax    
Email  amit.mhapuskar@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Rutuja Anil Jadhav 
Designation  Post-graduate student 
Affiliation  Bharati Vidyapeeth(Deemed to be University) Dental College and Hospital,Pune 
Address  Department of Oral Medicine and radiology, Room No.14, Bharati Vidyapeeth(Deemed to be University) Dental College and hospital, Pune
Dhanakawadi-Katraj, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9403667463  
Fax    
Email  rutuja.jadhav1-dchpune@bvp.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Rutuja Jadhav 
Address  Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune 
Type of Sponsor  Other [Self-funding(Not sponsored)] 
 
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 Rutuja Anil Jadhav  Bharati Vidyapeeth(Deemed to be University) Dental College and Hospital,Pune  Department of Oral Medicine and Radiology, Room No.14, Bharati Vidyapeeth(Deemed to be University) Dental College and Hospital, Pune Dhanakawadi-Katraj, Pune 411043
Pune
MAHARASHTRA 		 09403667463

rutuja.jadhav1-dchpune@bvp.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth (Deemed to be University) Pune, India Institutional Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M791||Myalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low level laser therapy in combination of topical analgesic gel  individuals in intervention i.e. STUDY GROUP A will receive a low level laser therapy using INDILASE Duo Dual Wavelength Diode laser-with TMJ 20 mm attachment (810 nm in a non contact mode, continuous wave 2.0-Watt power,600 Joule energy total,area-0.3 cm2 at light guide tip end, Duration-5 minutes i.e. 300 seconds) twice a week for 3 weeks along with topical application of analgesic gel(Diclofenac+Linseed oil) twice daily(which will be done by patient himself/herself) for 3 weeks duration. An appropriate safety measures like wearing of safety goggles and recommended protocols will be employed for both operator and patient.  
Comparator Agent  Placebo laser with topical application of analgesic gel  individuals in comparison i.e. STUDY GROUP B will receive placebo laser sessions(laser equipment on a standby mode where there is no laser emission) twice a week for 3 weeks along with topical application of analgesic gel twice daily for 3 weeks (which will be done by patient himself/herself).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with clinical diagnosis of Myofascial Pain Dysfunction Syndrome (MPDS) [LASKINS Criteria]
and Patients willing to provide informed consent to participate in the study and for follow up.  
 
ExclusionCriteria 
Details  1)Patients with underlying neurological disorders.
2)Patients with osteoarthritic changes.
3)Patients with history of any facial trauma or surgery.
4)Pregnant or lactating women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain, tenderness, Maximum mouth opening  Day 1,3,7,10,14,17,21 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence  Follow up phase once a week for next 4 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/09/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study aims to compare the efficacy of Combination Therapy (Low Level Laser Therapy (LLLT) and Topical Analgesic) with Topical Analgesic Therapy alone in patients with Myofascial Pain Dysfunction Syndrome (MPDS).
 Patients visiting OPD with chief complaint of pain in cheek, ear, lower jaw region/reduced 
mouth opening between age groups 18-60 years of either gender will be selected . 
Detailed case history of these patients will be recorded and based on clinical examination 
patients diagnosed for MPDS based on LASKINS CRITERIA will be included in the study.  
Laskin has proposed 4 cardinal signs and symptoms and two negative characteristics for MPDS. 
A. Positive cardinal signs and symptoms- 
1.Pain 
2.Muscle tenderness 
3.Clicking or popping in TMJ 
4.Limitation of jaw movement with deviation or deflection 
B. Negative Characteristics 
1.An absence of clinical, radiographic or biochemical evidence of organic changes in  joint 
2.Lack of tenderness in joint
A proforma assessment will be done for each selected patients with MPDS and all the details will be 
recorded.  
 Detailed information of the study will be given to all the individuals .  
Patients fulfilling the inclusion and exclusion criteria and ready to willingly participate in the study will 
be enrolled for the study.  
A written informed consent will be obtained.   After obtaining consent, patients will be assigned to groups. 
 The study will consist of 50 patients of either gender.  
  Study Group A-25 will receive LLLT with topical application of analgesic gel.  
 Control group B-25 will receive placebo laser session along with the topical application of analgesic gel.  
 A total duration of study is 7 weeks.  
 It consists of two phases- 
1. Active (Treatment) Phase for 3 weeks  
2.Passive (follow-up) Phase for next 4 weeks  
 In active treatment phase, individuals in STUDY GROUP A will receive a low level laser therapy using 
INDILASE Duo Dual Wavelength Diode laser-with TMJ 20 mm attachment (810 nm in a non
contact mode, continuous wave 2.0-Watt power,600 Joule energy total,area-0.3 cm2 at light guide 
tip end, Duration-5 minutes i.e. 300 seconds) twice a week for 3 weeks along with topical application 
of analgesic gel(Diclofenac and Linseed oil) twice daily(which will be done by patient himself/herself) for 3 
weeks duration.  
 And, individuals in STUDY GROUP B will receive placebo laser sessions(laser equipment on a standby 
mode where there is no laser emission) twice a week for 3 weeks along with topical application of 
analgesic gel twice daily for 3 weeks (which will be done by patient himself/herself).  
 An appropriate safety measures like wearing of safety goggles and recommended protocols will be 
employed for both operator and patient.  
 After completion of treatment, patient will be re-called for follow-up visit once every week for next 4 
weeks to check any recurrences.  
This study will help to plan a proper treatment protocol for patients with myofascial pain dysfunction syndrome.
 
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