| 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
|
|
|
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
|
|
|
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
|
|
|
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. |