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Can Jaw Pain Be Treated Better? A Study on Blood-Based Injections With or Without Joint Cleaning

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/093994
Enrollment
30
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M259- Joint disorder, unspecified Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: 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 as

Sponsors

Kirthi George
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Assessment of pain?VISUAL ANALOGUE SCALE (horizontal graded linear)Timepoint: 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

MeasureTime frame
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)Timepoint: 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 palpationTimepoint: 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 crepitusTimepoint: 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.

Countries

India

Contacts

Public ContactKirthi George

Post graduate institute of medical education and research, Chandigarh

kirtigeorge13@gmail.com7350666204

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026