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CompletedNCT07571265Updated May 6, 2026

Intra-articular Injection for the Relief of Temporomandibular Joint Pain

An interventional study of platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection in Temporomandibular Arthritis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled May 2024, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Which is more effective in the treatment of nonspecific temporomandibular osteoarthritis: platelet-rich plasma (PRP), hyaluronic acid, or triamcinolone acetonide?

Read the detailed description

Osteoarthritis is a degenerative condition that affects the TMJ. This condition may affect other joints in the hands, feet, or spine. The progressive destruction of the fibrocartilage layers with or without bone destruction and loss of the synovial fluid leads eventually to the accumulation of the inflammatory mediators. And when the episodes of destruction exceed that of healing, the patients start to encounter cycles of pain, inflammation, earache, limitation of mouth opening, and loss of function. Many treatment modalities have been illustrated in the literature for the treatment of osteoarthritis. One of the most effective treatment modalities used is intra-articular injections.

The first treatment strategy in this research is intra-articular injections of hyaluronic acid. Hyaluronic acid is a high molecular weight glycosaminoglycan composed of repeated chains of disaccharides. HLA is considered a normal component of numerous body structures and body fluids, like the synovial fluid, and is conjugated with many processes, like tissue repair and inflammation. So many authors advocate its usefulness in the treatment of temporomandibular dysfunction and myofascial pain without any complications or adverse effects.

The second treatment arm will be used for corticosteroids as intra-articular injections, and that's because of their long-standing and powerful anti-inflammatory properties alone or with local anesthetics for relief or treatment of temporomandibular joint symptoms.

Platelet-rich plasma is concentrated from the patient's own blood sample by centrifugation. It was first introduced in maxillofacial and plastic surgery in 1990. It's claimed that it has many advantages because of its healing potential, cell recruitment, proliferation, and differentiation, which lead eventually to tissue repair.

In this research, we are going to compare the effectiveness of three treatment arms: platelet-rich plasma, hyaluronic acid, and triamcinolone acetonide.

02

Conditions studied

  • Temporomandibular Arthritis
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 1. Patients with temporomandibular joint osteoarthritis with or without disc displacement.
  • 2. Age ≥ 18 years \< 50

Exclusion criteria

Exclusion Criteria:

  • 1. Previous TMJ surgery
  • 2. Medical history of blood-derived illness or any medication known to affect platelet function or concentration for a minimum of two weeks prior to treatment.
  • 3. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
  • 4. pregnant women or breastfeeding ones
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    platelet rich plasma(PRP)

    * The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP, and Patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months

    Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection

  • Active comparator
    triamcinolone acetonide

    * The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of epirelefan (triamcinolone acetonide) 40 mg/ml, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months

    Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection

  • Active comparator
    hyaluronic acid

    * The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of Hyalgan (hyaluronic acid) 20 mg/2 ml, and patients will be evaluated after one week, 1 month, and then 3 months. and 6 months

    Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection

  • Placebo comparator
    saline(placebo)

    * The surgical field will be prepared using alcohol before injection. * The entrance point for intraarticular injection is located along the canthotragal line, 10 mm from the middle of the tragus and 2 mm below the line. * Auriculotemporal nerve block anesthesia will be performed. * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of saline, and patients will be evaluated after one week, 1 month, and then at 3 months. and 6 months

    Other: platelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection

Interventions

  • Otherplatelet rich plasma and triamcinolone acetonide and hyaluronic acid and saline intra articular injection

    * An 18-gauge needle of a 10 ml plastic syringe loaded with normal saline solution will be inserted into the superior joint compartment (SJC). The injection-ejection process was repeated 10 times. Then the SJC will be injected with 1 ml of PRP in group I, 1 ml of triamcinolone acetonide 40 mg/ml in group II, 1 ml of hyaluronic acid (Hyalgan 20 mg/2 ml) in group III, or 1 ml of normal saline in group IV. * Patients will be evaluated after one week and 1 month, then at 3 months and 6 months.

06

What researchers measure

Primary outcomes

  1. pain intensity

    The patient's temporomandibular joint pain was felt by the patient on the visual analog scale from numbers 1 to 10.

    Time frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months

  2. pain-free mouth opening

    The maximum mouth opening measured with a caliper in millimeters.

    Time frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months

Secondary outcomes

  1. crepitus sounds

    asking the patient at every appointment

    Time frame: preoperative as baseline then after one week, 1 month, 3 months and 6 months

07

Study locations

1 site
  • Faculty of Dentistry
    Al Manyal, Cairo Governorate 11553, Egypt
08

References and documents

Individual participant data

Plan to share: No — The data is available with the corresponding author on reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07571265
Lead sponsor
Cairo University
Responsible party
mohamed mostafa abd el khalek mohamed (master student, Cairo University) — Principal investigator
First posted
May 6, 2026
Start date
May 1, 2024
Primary completion
Aug 25, 2025
Completion
Oct 25, 2025
Last update
May 6, 2026

Study contacts

Mohamed MA el saadany, master
principal investigator · mohamed_mostafa@dentistry.cu.edu.eg

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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