| CTRI Number |
CTRI/2025/09/094267 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Light Therapy and Medications for Jaw Muscle Pain Relief |
|
Scientific Title of Study
|
Evaluating the relative efficacy of photobiomodulation and pharmacotherapeutic agents in the symptomatic management of myogenous temporomandibular disorders |
| 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 Javvadi Durga Keerthi Mounavica |
| Designation |
Post Graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Block-3,Room No-1,
Department of Oral Medicine and Radiology,
Vishnu Dental College,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8328268665 |
| Fax |
|
| Email |
drkeerthiprasadjavvadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KJyothirmai |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Block-3,Room No-1,
Department of Oral Medicine and Radiology,
Vishnu Dental College,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
|
| Email |
jyothirmaik@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr KJyothirmai |
| Designation |
Professor and Head |
| Affiliation |
Vishnu Dental College |
| Address |
Block-3,Room No-1,
Department of Oral Medicine and Radiology,
Vishnu Dental College,
Vishnupur,
Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9866432477 |
| Fax |
|
| Email |
jyothirmaik@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,
Vishnupur,
Bhimavaram-534202,
West Godavari District,
Andhra Pradesh,
India |
|
|
Primary Sponsor
|
| Name |
Dr Javvadi Durga Keerthi Mounavica |
| Address |
Block-3,Room No-1,
Department of Oral Medicine and Radiology,
Vishnu Dental College,
Vishnupur,
Bhimavaram,
West Godavari District,
Andhra pradesh,
India
|
| 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 Javvadi Durga Keerthi Mounavica |
Vishnu Dental College |
Department of Oral Medicine and Radiology, Room no- 1, Bloack -3, Vishnu Dental College,
Vishnupur,
Bhimavaram,
India
West Godavari
ANDHRA PRADESH |
8328268665
08816250894
drkeerthiprasadjavvadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ibuprofen-400mg, Paracetomol-325mg, Chlorozoxazon-250mg |
twice daily for 7 days |
| Intervention |
Photobiomodulation |
1064nm Nd:YAG, 0.6W/cm2 for 60 seconds per cycle for two cycles for 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed as myogenous Temporomandibular joint disorders based on research diagnostic criteria |
|
| ExclusionCriteria |
| Details |
1.Previously treated/ ongoing treatment/ any recurrence.
2.History of Macro trauma
3.Patients with Renal impairment and Hepatotoxicity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of pain reduction |
Evaluation of pain reduction- baseline, day 0, 2, 4, 6 (postperatively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in Mouth Opening |
baseline, day-2, day-4, day-6, 1-month, 2-month & 3-month |
|
|
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)
|
15/09/2025 |
| 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="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to compare two different treatment approaches for managing this condition: traditional medications versus a non-invasive therapy known as photobiomodulation. A total of 30 adult patients diagnosed with myogenous TMD at the Department of Oral Medicine and Radiology will participate in the study. These patients have not received any prior treatment, have no history of trauma, and are experiencing their symptoms for the first time. Participants will be randomly divided into two groups: · Group A will receive standard pharmacological treatment including a combination of ibuprofen (400 mg), paracetamol (325 mg), and chlorzoxazone (250 mg). They will be monitored regularly for changes in symptoms. · Group B will receive photobiomodulation therapy, which uses a specific type of laser light (1064 nm Nd:YAG) applied at a low intensity (0.6 W/cm²) to muscle trigger points for 60 seconds on alternate days. This method is designed to reduce pain and inflammation at the muscle level. Both groups will be followed up over the course of one month to observe improvements in symptoms. The main goal of the study is to determine which treatment helps relieve pain more effectively and more quickly. |