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CTRI Number  CTRI/2024/12/077590 [Registered on: 03/12/2024] Trial Registered Prospectively
Last Modified On: 02/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study on the Effectiveness of Low-Level Laser Therapy using Different Wavelengths in Reducing Pain and Improving Jaw and Neck Movements in Patients with Jaw Joint Disorders 
Scientific Title of Study   Comparative effectiveness of Low-Level LASER Therapy of different wavelengths in patients with temporomandibular joint disorders: 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  Subhadeep Pal 
Designation  Junior Resident 
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
India 
Phone  8670970255  
Fax    
Email  subhadeeppal409@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
India 
Phone  9451525522  
Fax    
Email  adit@bhu.ac.in  
 
Details of Contact Person
Public 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
India 
Phone  9451525522  
Fax    
Email  adit@bhu.ac.in  
 
Source of Monetary or Material Support  
Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanai, Uttar Pradesh. Pin- 221005. India 
 
Primary Sponsor  
Name  SUBHADEEP PAL 
Address  Unit of Oral Medicine and Radiology, Faculty of Dental Sciences, Institute of Medical Sciences, Banaras Hindu University, Varanasi Uttar Pradesh Pin- 221005 India 
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 ADIT  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
Varanasi
UTTAR PRADESH 		 9451525522

adit@bhu.ac.in 
 
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 
Intervention  Low-level LASER therapy with 660 nm wavelength of LASER  Patients will be irradiated with 660 nm diode LASER, continuous wave, contact mode with 200 mw power, 30 sec on each cm2 area (i.e. 6J energy/ cm2). 2 sessions/week will be given for 4 weeks on bilateral TMJ, masseter, temporalis, trapezius and sternocleidomastoid muscles at predetermined points. 
Comparator Agent  Low-level LASER therapy with 810 nm wavelength of LASER  Patients will be irradiated with 810 nm diode LASER, continuous wave, contact mode with 200 mw power, 30 sec on each cm2 area (i.e. 6J energy/ cm2). 2 sessions/week will be given for 4 weeks on bilateral TMJ, masseter, temporalis, trapezius and sternocleidomastoid muscles at predetermined points. 
Comparator Agent  Low-level LASER therapy with dual wavelength (660 nm + 810 nm) of LASER  Patients will be irradiated with dual wavelength diode LASER (660 nm + 810 nm), continuous wave, contact mode with 200 mw power, 30 sec on each cm2 area (i.e. 6J energy/ cm2). 2 sessions/week will be given for 4 weeks on bilateral TMJ, masseter, temporalis, trapezius and sternocleidomastoid muscles at predetermined points. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients clinically diagnosed with TMD as per the latest version of RDC/TMD.
Patients willing to participate who have given consent for the study.
Patients with blood parameters (CBC, RA Factor and Uric Acid) levels within normal limits. 
 
ExclusionCriteria 
Details  Subjects with history of orthodontic/prosthodontic treatment.
Subjects with history of trauma/surgery of the TMJ.
Subjects with history of previous treatment for the same complaint.
Subjects with OPG showing degenerative changes in the mandibular condyle e.g. rheumatoid arthritis, osteoarthritis. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain score (Numeric Rating Scale- NRS)  Baseline, 1 Week, 2 Week, 3 Week, 4 Week 
 
Secondary Outcome  
Outcome  TimePoints 
Mandibular range of motion (maximum mouth opening, maximum left & right lateral excursion, maximum protrusion)  Baseline, 1 Week, 2 Week, 3 Week, 4 Week 
Cervical range of motion (maximum flexion, maximum posterior extension, maximum left & right extension, maximum left & right rotation)  Baseline, 1 Week, 2 Week, 3 Week, 4 Week 
Changes in electromyographic activity of masseter, temporalis, sternocleidomastoid, trapezius muscles (microvolts)  Baseline, at the end of 4 Week 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   20/12/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 of the study: 1. To assess the effectiveness of low -level LASER therapy with three different wavelengths- 660 nm, 810 nm, and combined dual-wavelength (simultaneous 660 nm + 880 nm) in the management of temporomandibular joint disorders on the basis of changes in pain score using Numeric Rating Scale (NRS), mandibular range of motion, cervical range of motion and electromyographic studies. 2. To compare the effectiveness of three different wavelengths- 660 nm, 810 nm, and combined dual-wavelength (simultaneous 660 nm + 880 nm) amongst themselves.

Null Hypothesis: There is no difference in various treatment outcomes (e.g. changes in pain score using Numeric Rating Scale, mandibular range of motion, cervical range of motion and electromyographic studies) among low-level LASER therapy with three different wavelengths 660 nm, 810nm, and combined dual-wavelength (660 nm + 880 nm) in the treatment of temporomandibular disorders.

Source of data: Data will be collected from patients reporting to the Out-Patient Unit of Oral Medicine and Radiology in the Faculty of Dental Sciences, I.M.S., B.H.U. Patients fulfilling the inclusion criteria will be selected. Diagnosis of TMD would be based on the patient’s history and clinical features.

Method of collection of data

Sampling technique- Simple Random Sampling

Sample size determination- Sample size was calculated with α = 0.05, power of study at 80% and Type II error 0.20 by substituting the values obtained in a previous study, in G*power 3.1.9.7 software. The sample size obtained was 25 per group. (Carrasco, Thaise Graciele et al. “Low intensity laser therapy in temporomandibular disorder: a phase II double-blind study.” Cranio : the journal of craniomandibular practice vol. 26,4 (2008): 274-81. doi:10.1179/crn.2008.037)

Study design- Randomized Controlled Trial. Samples will be of age 18 to 50 years. Matching will be done for age.

Materials-

1. Basic examination kit (kidney tray, explorer, mouth mirror, tweezers, stethoscope, mask, and disposable gloves)

2. Orthopantomogram

3. Digital callipers

4. Goniometer

5. Electromyography machine and associated armamentarium

6. Diode LASER device with 660 nm, 810 nm and dual wavelength settings with associated armamentarium

Methods

1. Diagnosis of Temporomandibular Disorders will be made on the basis of clinical findings in accordance with the latest version of the RDC/TMD.

2. The study and treatment protocol will be explained to the patient in brief and the informed consent will be taken.

3. Baseline scoring of pain using NRS, measurements of cervical mobility using goniometer, measurements of mandibular movement using digital callipers and electromyographic studies of sternocleidomastoid, masseter, temporalis and trapezius muscles will be done preoperatively by a trained observer.

4. Patients will be randomly assigned to one of the three study groups consisting of 25 subjects each- Group 1 (680 nm), Group 2 (810 nm) and Group 3 (dual wavelength).

5. Group 1 patients will be irradiated with 660 nm diode laser, continuous wave, contact mode with 200 mw power, 60 sec on each cm2 area i.e. 6J/ cm2. 2 sessions/week will be given for 4 weeks on bilateral TMJ, masseter, temporalis, trapezius and sternocleidomastoid muscles at predetermined points.

6. Group 2 patients will be irradiated with 810 nm diode laser, continuous wave, contact mode with 200 mW power, 60 sec on each cm2 area i.e. 6J/ cm2. 2 sessions/week will be given for 4 weeks on bilateral TMJ, masseter, temporalis, trapezius and sternocleidomastoid muscles at predetermined points.

7. Group 3 patients will be irradiated with dual wavelength diode laser (660 + 810 nm), continuous  wave, contact mode with 200 mw power, 60 sec on each cm2 area i.e. 6J/ cm2. 2 sessions/week will be given for 4 weeks on bilateral TMJ, masseter, temporalis, trapezius and sternocleidomastoid muscles at predetermined points.

8. Subjects of all the experimental groups will be instructed to use their respective treatments as the only management modalities.

9. Measurements of NRS, cervical range of motion, and mandibular range of motion will be taken at baseline, at the end of 1 week, 2 week, 3 week and 4 week.

10. Electromyographic studies of masseter, temporalis, trapezius and sternocleidomastoid muscles will be taken at baseline and at the end of 4 weeks.

11. Comparative evaluation and statistical analysis of all parameters will be done after data collection.


 
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