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CTRI Number  CTRI/2026/01/101942 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 26/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of injectable blood derivative and LASER for treatment of muscular pain in facial region.  
Scientific Title of Study   Comparative Effectiveness of Injectable platelet-rich Plasma, Photo biomodulation Therapy, and Sequential Application of Platelet-Rich Plasma Followed by Photo biomodulation in management of myofascial trigger points in masseter muscle – A randomized clinical 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  DR AMBIKA GUPTA  
Designation  SENIOR PROFESSOR AN HEAD, ORAL MEDICINE AND RADIOLOGY, PGIDS, ROHTAK 
Affiliation  PGIDS, ROHTAK 
Address  ROOM NO. 11 DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, PGIDS, Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9315903300  
Fax    
Email  drambika79@rediffmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Sharika C.S. 
Designation  MDS Student 
Affiliation  PGIDS, Rohtak 
Address  Room No. 11 Department of Oral Medicine and Radiology, PGIDS, ROHTAK

Rohtak
HARYANA
124001
India 
Phone  8943557802  
Fax    
Email  sharikacs19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sharika C.S. 
Designation  MDS Student 
Affiliation  PGIDS, Rohtak 
Address  Room No. 11, Department of Oral Medicine and Radiology, PGIDS, ROHTAK.

Rohtak
HARYANA
124001
India 
Phone  8943557802  
Fax    
Email  sharikacs19@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Dental Sciences, Rohtak 
 
Primary Sponsor  
Name  Post Graduate Institute of Dental Sciences Rohtak 
Address  Dental College, University Campus, Pt. B.D.Sharma University of Health Sciences, Rohtak- 124001, Haryana, India 
Type of Sponsor  Government medical college 
 
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 AMBIKA GUPTA  PGIDS, ROHTAK  Room no. 11, Department of Oral Medicine and Radiology.
Rohtak
HARYANA 
09315903300

drambika79@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIOMEDICAL HEALTH RESEARCH ETHICS COMMITTEE, PGIDS, ROHTAK   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M791||Myalgia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Injectable platelet plasma in trigger point  Group 2 will receive 0.5 ml PRP injection in the trigger point in affected masseter muscle The injection will be repeated after 15 days if the percentage reduction in pain score is less than 50 percent from the baseline 
Intervention  Injectable PRP followed by PBM   Procedure to prepare PRP Liquid PRP will be prepared according to the PRP preparation protocol 8 A tourniquet tied to the patients arm and a 70 percent isopropyl alcohol swab will be used to clean the patients antecubital fossa 20 ml Blood will be drawn from the antecubital vein and will be transferred to 3.2 percent sodium citrate vacutainers The blood sample will be centrifuged using REMI medico plus centrifugation machine The anticoagulant mixed blood samples will be centrifuged at 1000 rpm for 10 minutes which results in the separation of the supernatant plasma The plasma will then be transferred to another plain vacutainer with the help of a syringe with a 16 gauge needle and then centrifuged at 1200 rpm for 10 minutes This results in the formation of a platelet pellet settled at the base of the plasma filled tube The upper two thirds portion of the plasma platelet poor plasma will be discarded and the pellet will be mixed in with the lower one third of the plasma The agitated solution thus prepared is the PRP which will be evaluated for the presence of a sufficient number of platelets before the injection Group 1 will receive 0.5 ml PRP injection in the trigger point in affected masseter muscle followed by photo biomodulation using a diode laser on the same day PBM will be repeated at the same point twice a week for 4 weeks  
Comparator Agent  photobiomodulation administrated on trigger point  Group 3 will receive laser photo biomodulation using diode laser twice a week for 4 weeks for 1 minutes during each session 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients diagnosed with myofascial pain as per DC TMD Ib with active trigger points involving masseter muscle
2 Patients consent for participation in the study
 
 
ExclusionCriteria 
Details  1 Patients with a phobia to needles
2 Patients who have undergone previous treatment for myofascial pain
3 Patients with active infection at the site of injection or overlying skin
4 Patients with a history of trauma to the maxillofacial region in past 6 months
5 Patients with other types of orofacial pain and musculoskeletal disorders.
6 Patients with parafunctional habits
7 Healing disorders or systemic diseases where healing is compromised
8 Patients on anticoagulant therapy
9 Bleeding and clotting disorders
10 Patients with epilepsy seizures
11 Pregnancy and lactation
12 Patients addicted to alcohol drugs
13 BDI in moderate and severe category
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
NRS for assessment of pain score
MO, PM, RTLEM, and LTLEM in mm for evaluation of functional movements.
 
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 3 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess patient satisfaction (Likert scale)
To evaluate the need for alternative treatment in both groups (as frequency)
To evaluate the side effects of injectable platelet rich plasma, photobiomodulation if any (as frequency)
 
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks and 3 months. 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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 4 
Date of First Enrollment (India)   01/02/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Rationale  A myofascial trigger point is a hyperirritable spot within a palpable taut band of muscle  Platelet rich plasma PRP therapy and Photo biomodulation PBM have both been used as a successful treatment modality for treating trigger points PBM has been found to have an additive effect to PRP by increased ATP production  reduction of oxidative stress and increased production of collagen in an in vitro study Hence the present study intends to compare  the effectiveness of  injectable PRP  photo biomodulation therapy and sequential application of platelet rich plasma followed by photo biomodulation in management of trigger point in masseter muscle

Research Question Is the sequential application of platelet rich plasma followed by photo biomodulation more effective compared to either PRP or PBM alone in the treatment of trigger points in masseter

P Population Patients with active myofascial trigger points in the masseter muscle

I Intervention Injectable PRP followed by PBM

C Comparator 1 Injectable platelet plasma followed by Photo biomodulation administrated on                                                   trigger point

Comparator 2 photobiomodulation administrated on trigger point

O Outcome pain intensity functional jaw movements

T Time Frame 1year 6 months

S Study Design randomized comparative trial

Setting in Haryana India

AIM AND OBJECTIVES

                                                                                                                                                  AIM  To evaluate the effectiveness of platelet rich plasma followed by photo biomodulation for treatment of trigger points in masseter muscle

OBJECTIVES

Primary objective 

1 To evaluate and compare the change in intensity of pain in all the study groups

2 To evaluate and compare the improvement in functional limitation of jaw in the three groups

 

Secondary objective

1 To assess patient satisfaction

2 To evaluate the need for alternative treatment modalities

3 To evaluate the side effects of PRP injection and PBM therapy                                                                                                                                                                                 

Materials and Methodology

Setting Department of Oral Medicine and Radiology  PGIDS  Rohtak Haryana

Study Design Randomized comparative trial

Study Duration  This study will be completed in 1 5 years

Population Patients suffering from myalgia with active trigger points in masseter muscle will be recruited in study from regular OPD of the Department of Oral Medicine and Radiology

Sample size  A total of 69 patients with 23 patients in each group

Methods  In group 1  Injectable PRP will be prepared and administrated in the trigger points in masseter muscle followed by the application of laser photo biomodulation of the trigger points  In group 2  Injectable PRP will be prepared and administrated in the trigger points in masseter muscle  In group 3 a Diode laser of 980nm will be applied to the trigger points in masseter muscle  twice weekly for 4 weeks

Outcome measures  Primary outcome measures will be

NRS assessment of pain intensity.

 Mean mouth opening MO in millimeters

 Range of right and left lateral excursive movements RTLEM and LTLEM respectively in  millimeters

 Range of protrusive movement PM in  millimeters

Secondary outcome measures will be

 Need for additional pain medicine number of tablets consumed per week

  Likert scale 1 5  assessment of patient satisfaction LPS

Statistical analysis  Data will be tabulated in Microsoft Excel sheet  All analysis will be performed by SPSS software Descriptive and inferential statistics will be used  Baseline assessment of all subjects will be done  All results shall be calculated at 5 percentage  significance level I e less than  0 05  Normality of dependent variable will be assessed by using Shapiro Wilk test Independent T test shall be used to compare pain between the two groups if data is normal else Mann Whitney U will be used

 
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