FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/092671 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Low-level LASER therapy with 810 nm wavelength of LASER ]  
Study Design  Other 
Public Title of Study   A Functional MRI Study Evaluating the Neuromodulatory Effects of Low-Level Laser Therapy in Patients with Temporomandibular Joint Disorders. 
Scientific Title of Study   Neuromodulatory Effects of Low-Level Laser Therapy (LLLT) in Temporomandibular Joint (TMJ) Disorders: A Functional MRI study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harshita Tiwari 
Designation  Junior resident 
Affiliation  Institute of medical sciences 
Address  Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University Varanasi UTTAR PRADESH 221005
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University Varanasi UTTAR PRADESH 221005
Varanasi
UTTAR PRADESH
221005
India 
Phone  07524072215  
Fax    
Email  harshitamgs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Adit 
Designation  Professor and head, Unit of Oral Medicine and Radiology 
Affiliation  Institute of medical sciences, Banaras Hindu University 
Address  Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University Varanasi UTTAR PRADESH 221005
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University Varanasi UTTAR PRADESH 221005
Varanasi
UTTAR PRADESH
221005
India 
Phone  9451525522  
Fax    
Email  adit@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Harshita Tiwari 
Designation  Junior resident 
Affiliation  Institute of medical sciences 
Address  Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University Varanasi UTTAR PRADESH 221005
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University Varanasi UTTAR PRADESH 221005

UTTAR PRADESH
221005
India 
Phone  07524072215  
Fax    
Email  harshitamgs@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Harshita Tiwari 
Address  Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University Varanasi UTTAR PRADESH 221005 
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 Harshita Tiwari  Faculty of Dental Sciences  Room no 1, Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH 		 7524072215

harshitamgs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethics Committee, Institute of Medical Sciences, Banaras Hindu University   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 
Comparator Agent  Group 1 of healthy controls with no TMD .  Control group will help to establish baseline neural activity. 
Intervention  Low-level LASER therapy with 810 nm wavelength of LASER   LLLT will be applied to TMJ-affected areas using a laser device : 810 nm diode laser, with continuous wave, contact mode with 100 mW, 60 sec on each cm2 area i.e. 6J/ cm2, 2 times/ week for 4 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients clinically diagnosed with TMD as per the latest version of RDC or TMD.
2.Patients willing to participate who have given consent for the study.
3. Patients with blood parameters (CBC, RA Factor and Uric Acid) levels within normal
limits.  
 
ExclusionCriteria 
Details  1.Subjects with history of orthodontic or prosthodontic treatment.
2.Subjects with history of trauma or surgery of the TMJ.
3.Subjects with history of previous treatment for the same complaint.
4. Subjects with OPG showing degenerative changes in the mandibular condyle e.g.
rheumatoid arthritis, osteoarthritis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical assessments of
Pain intensity using the Visual Analog Scale and
Jaw functional limitation using the Jaw Functional Limitation Scale will be done preoperatively by a trained observer.
 		 Baseline, 4 week 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate changes in neural activity in key pain-related brain regions (e.g., anterior cingulate cortex, insula, prefrontal cortex) following LLLT treatment in TMD patients.
2.To assess the impact of LLLT on functional connectivity within pain-processing networks, including the default mode network and salience network.
3.To correlate neural changes with clinical pain scores and functional improvement in TMJ disorders.

 		 Baseline , 4 Week 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/08/2025 
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="2"
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  
Objectives
To evaluate changes in neural activity in key pain-related brain regions (e.g., anterior cingulate cortex, insula, prefrontal cortex) following LLLT treatment.
To assess the impact of LLLT on functional connectivity within pain-processing networks, including the default mode network and salience network.
To correlate neural changes with clinical pain scores and functional improvement in TMJ disorders.
Study Design:
A prospective, longitudinal study with a pre-treatment and post-treatment assessment.
Participants:
15 patients diagnosed with TMJ disorders based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).
15 age- and gender-matched healthy controls for baseline comparisons.
Intervention:
LLLT will be applied to TMJ-affected areas using a laser device (e.g., 810 nm wavelength, 6J/cm² energy density) in 2 times per week for four weeks.
Data Collection:
Clinical Assessments:
Pain intensity using the Visual Analog Scale (VAS).
Jaw functional limitation using the Jaw Functional Limitation Scale (JFLS).
Neuroimaging Assessments:
fMRI scans pre- and post-LLLT treatment.
esting-state fMRI to evaluate functional connectivity in pain-related networks.
Task-based fMRI during nociceptive stimulation to assess regional brain activation.
Data Analysis:
Voxel-wise comparison of task-based fMRI activation maps before and after LLLT.
Correlation analysis between changes in neural activity/connectivity and clinical outcomes.
Expected Outcomes
LLLT will reduce pain-related activation in the anterior cingulate cortex, insula, and prefrontal cortex.
LLLT will enhance functional connectivity in pain-modulating networks.
The observed neural changes will correlate with reductions in pain intensity and improved jaw function, providing evidence of central mechanisms underlying LLLT’s efficacy.
 
Close