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CTRI Number  CTRI/2025/09/093994 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 31/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Can Jaw Pain Be Treated Better? A Study on Blood-Based Injections With or Without Joint Cleaning 
Scientific Title of Study   Comparison of intra-articular injection of platelet rich fibrin (i-prf) as a stand-alone treatment modality with concomitant use of arthrocentesis and i-prf in patients with temporomandibular disorders - a randomised 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  Kirthi George 
Designation  Junior resident 
Affiliation  Post graduate institute of medical education and research, Chandigarh 
Address  Unit of oral and maxillofacial surgery, Oral Health Science Centre, PGIMER Chandigarh
Room no. 104, Oral and maxillofacial surgery, Oral health science centre, PGIMER Hospital Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  7350666204  
Fax    
Email  kirtigeorge13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kirthi George 
Designation  Junior resident 
Affiliation  Post graduate institute of medical education and research, Chandigarh 
Address  Room no. 104, Oral and maxillofacial surgery, Oral health science centre, PGIMER Hospital Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7350666204  
Fax    
Email  kirtigeorge13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kirthi George 
Designation  Junior resident 
Affiliation  Post graduate institute of medical education and research, Chandigarh 
Address  Unit of Oral and maxillofacial surgery, Oral health science centre, PGIMER Hospital Chandigarh
Room no. 104, Oral and maxillofacial surgery, Oral health science centre, PGIMER Hospital Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  7350666204  
Fax    
Email  kirtigeorge13@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research ,Chandigarh 
 
Primary Sponsor  
Name  Kirthi George 
Address  Room no. 104, Oral and maxillofacial surgery, Oral health science centre, PGIMER Hospital Chandigarh 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kirthi George  Post graduate institute of medical education and research, Chandigarh  Room no. 104, Oral and maxillofacial surgery, Oral health science centre, PGIMER Hospital Chandigarh
Chandigarh
CHANDIGARH 
07350666204

kirtigeorge13@gmail.com 
Professor Dr Vidya Rattan  Post graduate institute of medical education and research, Chandigarh  Oral and maxillofacial surgery, Oral health science centre, PGIMER Hospital Chandigarh
Chandigarh
CHANDIGARH 
9914900871

drvidyarattan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, PGIMER chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M259||Joint disorder, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  i-PRF + arthrocentesis   A single examiner will enrol the participants. Random allocation of the patient will be done using sequentially numbered opaque sealed envelopes. All aspects of the study will be approved by the institutional Ethics committee. All the patients will be first treated conservatively and patients not having relief post 3 months will be included in the study. The conservative treatment regime would include soft diet, warm compresses, mandibular exercises, analgesic medication Tab. Diclofenac sodium 50mg twice daily, Vitamin D3 supplements and Tab. Rejoint containing Glucosamine Sulphate and Chondroitin Sulphate as active ingredients. A written informed consent of all the patients undergoing study will be obtained prior to the inclusion in the study after the patient meets inclusion/exclusion criteria. There will be a total of 2 groups. Each participant would be randomly allocated.The comparator group will undergo arthrocentesis followed by intra-articular injection of i-PRF  
Intervention  Injectable platelet rich fibrin  A single examiner will enrol the participants. Random allocation of the patient will be done using sequentially numbered opaque sealed envelopes. All aspects of the study will be approved by the institutional Ethics committee. All the patients will be first treated conservatively and patients not having relief post 3 months will be included in the study. The conservative treatment regime would include soft diet, warm compresses, mandibular exercises, analgesic medication Tab. Diclofenac sodium 50mg twice daily, Vitamin D3 supplements and Tab. Rejoint containing Glucosamine Sulphate and Chondroitin Sulphate as active ingredients. A written informed consent of all the patients undergoing study will be obtained prior to the inclusion in the study after the patient meets inclusion/exclusion criteria. There will be a total of 2 groups. Each participant would be randomly allocated. The intervention group would be administered intra-articular injection of i-PRF  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with TMD Wilkes stage III, IV, V (DC TMD Criteria 2015)

Patients not having relief from conservative treatment for at least 3 months with VAS score more than 5

Age group 18-65 years, regardless of gender

Patients willing to give written informed consent
 
 
ExclusionCriteria 
Details  Autoimmune disorders -Benign or malignant lesion of the temporomandibular joint, Neurological disorders- Bruxism

Blood disorders and coagulopathies

Patients with a history of allergy or anaphylactic shock

Severe malocclusion- Crowding, Anterior deep bite

Patients with acute infectious disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain—VISUAL ANALOGUE SCALE (horizontal graded linear)  Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.  
 
Secondary Outcome  
Outcome  TimePoints 
The range of mandibular motion (maximum unassisted opening (MUO), maximum assisted opening (MAO), protrusive movement (PM), right lateral excursion (RLE) and left lateral excursion (LLE)  Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.  
Tenderness of masticatory muscles (masseter and temporalis) – by manual palpation  Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.  
Clicking sound and crepitus  Evaluation will be carried out at 14 days, 1 month, 2 months and 3 months post intervention. The change in VAS score [from baseline to VAS at 3 months (VAS T4)] will be considered as the primary outcome.  
 
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   Phase 4 
Date of First Enrollment (India)   11/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/09/2025 
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  

Temporomandibular disorders represent a wide range of functional changes and pathological conditions affecting the temporomandibular joint, masticatory muscles, and other components of the oro-maxillofacial region. In recent years, TMD has become a frequent cause for seeking medical assistance. Their multifactorial etiology and diverse presentation necessitate evidence-based, minimally invasive management strategies tailored to optimize clinical outcomes.

Management is mainly focused on relieving the functional pain and re-establishing normal range of mandibular function. From the range of surgical alternatives available, arthrocentesis has been widely used since many decades. In conjunction with arthrocentesis, intra-articular administration of various substances has been used. The injectables studied so far include corticosteroids, hyaluronic acid, tenoxicam, morphine, bupivacaine, local anaesthesia-steroid combination, hypertonic dextrose, analgesics, ozone, and auto-derived preparations. The currently used autologous products are mainly substances obtained from the patient’s centrifuged blood: platelet-rich plasma, plasma rich in growth factor, and injectable platelet-rich fibrin, of the most favourable composition.

Arthrocentesis followed by intra-articular injection of i-PRF has been the standard of care recently. The advantage of injecting PRF in TMJ is that each PRF injection causes a mechanical tear of adhesions through a hydraulic distension and expansion of the superior articular space, thereby eliminating the vacuum effect present in osteoarthritis. It is established that PRF can reduce pain and has growth factors incorporated.

At present, PRF has more advantages and appears be a better choice, whereas further research is required to prove the long-term efficacy of PRF to avoid the invasive procedure of arthrocentesis.

Intraarticular administration of i-PRF is better tolerated by the patient owing to its less invasiveness. Evaluating the effectiveness of arthrocentesis prior to administration of intra-articular injection of i-PRF is necessary to prevent over-treating the joint. The lack of RCTs on the intra-articular administration of I-PRF as a stand-alone procedure encourages further research. Hence, we have proposed to conduct a Randomised Clinical Trial to compare the efficacy of intra-articular injection of i-PRF as a stand-alone treatment modality to the current trend of arthrocentesis followed by intra-articular injection of i-PRF in patients with Temporomandibular disorders. 
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