Intra-articular Injection for the Relief of Temporomandibular Joint Pain

NCT07571265 | Completed

• 1 other identifier: Intra articular injections
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Temporomandibular Arthritis

Outcome Measures

Primary Outcomes (2)

• pain intensity

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

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

• pain-free mouth opening

  The maximum mouth opening measured with a caliper in millimeters.

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

Secondary Outcomes (1)

• crepitus sounds

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

Study Arms (4)

platelet rich plasma(PRP)

ACTIVE COMPARATOR

* 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

triamcinolone acetonide

ACTIVE COMPARATOR

* 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

hyaluronic acid

ACTIVE COMPARATOR

* 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

saline(placebo)

PLACEBO COMPARATOR

* 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

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

* 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.

hyaluronic acid; platelet rich plasma(PRP); saline(placebo); triamcinolone acetonide

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. Previous TMJ surgery
• \. 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.
• \. specific osteoarthritis like rheumatoid arthritis or psoriatic arthritis.
• \. pregnant women or breastfeeding ones

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Al Manyal, Cairo Governorate, 11553, Egypt

Location

MeSH Terms

Interventions

Triamcinolone Acetonide; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Mohamed MA el saadany, master

  mohamed_mostafa@dentistry.cu.edu.eg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcome assessor is blinded because the injected materials have different form and physical characteristics.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master student

Model Details: * 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 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, 1 month, and then at 3 months and 6 months.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2024
• Primary Completion: August 25, 2025
• Study Completion: October 25, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)