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CTRI Number  CTRI/2026/02/104397 [Registered on: 20/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study of Two Groups Receiving Either a Muscle-Relaxing Tablet or Laser Therapy for Jaw Muscle and Joint Pain, with Measurement of Pain Relief and Jaw Function 
Scientific Title of Study   Comparison of the efficacy of a muscle relaxant-Tizanidine with Low level laser therapy in treatment of Myofascial and TMJ pain dysfunction syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rupak Biswas 
Designation  OMFS post graduate student 2nd year 
Affiliation  NAIR HOSPITAL DENTAL COLLEGE 
Address  NAIR HOSPITAL DENTAL COLLEGE OMFS dept Room 107 Near maratha mandir pin 400008 Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8258010781  
Fax    
Email  brupak598@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rupak Biswas 
Designation  OMFS pg 
Affiliation  NAIR HOSPITAL DENTAL COLLEGE 
Address  Sukhakarta housing society near one avighna park lower parel east mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  8258010781  
Fax    
Email  brupak598@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rupak Biswas 
Designation  OMFS pg 
Affiliation  NAIR HOSPITAL DENTAL COLLEGE 
Address  NAIR HOSPITAL DENTAL COLLEGE OMFS dept PG section room 107 near maratha mandir mumbai 400008

Mumbai
MAHARASHTRA
400008
India 
Phone  8258010781  
Fax    
Email  brupak598@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Rupak Biswas 
Address  NAIR HOSPITAL DENTAL COLLEGE dept of OMFS room107 phone-8258010781 MUMBAI CENTRAL NEAR MARATHA MANDIR MUMBAI400008 
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 Rupak Biswas  NAIR HOSPITAL DENTAL COLLEGE  NAIR HOSPITAL DENTAL COLLEGE MUMBAI CENTRAL NEAR MARATHA MANDIR Room 107 1st floor old building dept of Oral and Maxillofacial surgery PG section MFD
Mumbai
MAHARASHTRA 
8258010781

brupak598@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee-Nair Hospital Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M248||Other specific joint derangements,not elsewhere classified, (2) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Low level laser therapy  Low level laser therapy is a non invasive treatment modality that uses low intensity laser light to stimulate cellular activity and promote pain relief reduce inflammation and enhance tissue healing without causing thermal damage to tissues. frequency 2 sessions in a week for total 2 weeks  
Intervention  Tizanidine  Patients will receive a standard dose of Tizanidine (4 mg daily) for 2 weeks. In this group also, diclofenac tablets will be provided to all patients as Rescue medication to be taken as needed tizanidine 2 tablets in a day for 14 days and tab diclofenac on sos basis 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Individuals diagnosed with TMJD and MPDS.
2.Age between 18 to 60 years.
3.Individuals willing to participate in the study 
 
ExclusionCriteria 
Details  1.Pregnant or breastfeeding women.
2.Individuals with any neurological disorders.
3.Those Individuals who are undergoing concurrent TMJ surgeries or interventions.
4.Individuals with history of trauma in TMJ region.
5.Individuals allergic to medications proposed to be used in the study sensitive to red light.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Red Light Therapy is equally effective as muscle
relaxants in reducing pain in patients with TMJD and MPDS.
 
Baseline
day 7
day 14
after one month for long term effects
 
 
Secondary Outcome  
Outcome  TimePoints 
Inclusion of an anti-inflammatory medication as part of treatment protocol improves the overall outcome in patients with TMJD and MPDS   Follow up on days 7, and 14 & up to a period of one month after start of therapy  
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   02/03/2026 
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="4"
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 study will include patients attending the outpatient department of Oral and Maxillofacial Surgery with symptoms of myofascial pain dysfunction syndrome and temporomandibular joint disorders such as pre auricular pain reduced mouth opening muscle tenderness and TMJ sounds. All eligible patients will be enrolled after thorough history taking with special attention to any past allergic reactions to muscle relaxants or analgesics.

After obtaining informed consent patients will be randomly divided into two groups. Group A will receive red light therapy using a low level laser of 660 nm wavelength for three minutes per session three times per week for two weeks along with diclofenac as rescue medication. Group B will receive tizanidine four milligrams once daily for two weeks along with diclofenac as rescue medication. All medications will be provided free of cost.

Baseline assessment will include pain evaluation using visual analog scale measurement of mouth opening and assessment of TMJ sounds. Patients will be followed up on day seven day fourteen and up to one month after treatment to evaluate pain reduction improvement in jaw mobility muscle relaxation and TMJ sounds. Patients will also report the number of diclofenac tablets consumed which will be recorded for analysis.

 
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