| CTRI Number |
CTRI/2025/07/091454 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two treatments made from a patient’s own blood — PRP and SPL — to see which works better for relieving jaw joint problems |
|
Scientific Title of Study
|
Evaluation of efficacy of platelet rich plasma (PRP) and sonicated platelet lysate (SPL) in the management of temporomandibular joint disorders – a randomized controlled 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 Kumar Rakshak Anand |
| Designation |
Professor and Head |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9711410024 |
| Fax |
|
| Email |
gr8doctor41@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Bansal |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9971338761 |
| Fax |
|
| Email |
doc.neerajbansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Bansal |
| Designation |
Senior Lecturer |
| Affiliation |
Manav Rachna Dental College |
| Address |
Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
9971338761 |
| Fax |
|
| Email |
doc.neerajbansal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental College |
|
|
Primary Sponsor
|
| Name |
Manav Rachna Dental College |
| Address |
Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana
Faridabad
HARYANA
121004
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kumar Rakshak Anand |
Manav Rachna Dental College |
Room no - QG43, Department of Oral and Maxillofacial Surgery, Manav Rachna Dental College, Manav Rachna International Institute of Research and Studies (MRIIRS), Sector – 43, Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana - 121004
Faridabad
HARYANA |
9711410024
rakshak.sds@mrei.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MRDC, SDS, MRIIRS |
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 |
Platelet-Rich Plasma (PRP) |
The comparator is Platelet-Rich Plasma (PRP), prepared from 5 mL autologous blood using double centrifugation (250g × 10 min, 2000g × 10 min). A 0.5–1 mL intra-articular PRP injection is given into the TMJ. Follow-up will be done at 7 days, 1, 3, 6, and 12 months. |
| Intervention |
Sonicated Platelet Lysate (SPL) |
SPL, the intervention, is derived from 5 mL autologous blood using centrifugation and ultrasonication (20 kHz × 30 min) to release growth factors. A single 0.5–1 mL intra-articular injection is given into the TMJ, with follow-up at 7 days, 1, 3, 6, and 12 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients not responding to conservative treatment
2. Patients who comes under stage 2 and stage 3 of Wilke’s classification of internal derangement or having TMJ osteoarthritis
|
|
| ExclusionCriteria |
| Details |
1. Age group less than 18
2. Prior TMJ surgery
3. Relief with conservative treatment
4. Systemic disorder and immunocompromised patients
5. Patients under antiplatelets, anticoagulants, steroids or Immunosuppressant medication
6. Patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
FUNCTIONAL (clinical)
1. Maximum mouth opening
2. Tenderness on palpation
3. Clicking
4. Jaw deviation
|
preoperatively, 7days, 1month, 3 months, 6 months and 12 months postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MORPHOLOGICAL (radiographic)
Joint morphology using MRI
|
preoperatively and 12 months postoperatively |
| QUALITY OF LIFE |
6 month and 12 months postoperatively |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/08/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
Temporomandibular Joint Disorders (TMD) are musculoskeletal conditions causing pain, joint dysfunction, and impaired jaw movement. Traditional treatments offer only temporary relief and lack regenerative potential. This randomized controlled clinical trial aims to compare the efficacy of Platelet-Rich Plasma (PRP) and Sonicated Platelet Lysate (SPL) in improving pain, jaw function, and joint structure in patients with TMD.
A total of 34 patients not responding to conservative therapy will be randomly assigned to receive either PRP or SPL intra-articular injection. The primary outcomes include pain relief (Visual Analogue Scale) and functional improvement (mouth opening, jaw deviation, joint sounds). Secondary outcomes include MRI-based morphological changes and quality of life assessments.
Clinical assessment will be done preoperatively and at 7 days, 1 month, 3 months, 6 months, and 12 months postoperatively. Radiographic assessment using MRI will be conducted preoperatively and at 12 months. Quality of life will be assessed at 6 and 12 months post-treatment. Both participants and outcome assessors will be blinded to the group assignments to ensure objective evaluation.
The study aims to identify the more effective biologic therapy and promote a minimally invasive, evidence-based approach for TMD management. |