| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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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 |
|
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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
|
|
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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. |
|
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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
|
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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. |