| 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
|
|
|
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
|
|
|
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 |