Effect of Intraarticular Injection of Tenoxicam and Hyaluronic Acid Versus Platelet-Rich Plasma and Hyaluronic Acid in Temporomandibular Joint Internal Derangement

NCT06572904 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: TMJ ID
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the effect of intraarticular injection of Tenoxicam and Hyaluronic acid Versus Platelet-rich plasma and Hyaluronic acid in the management of patients with TMJ internal derangement with reduction.

Conditions

Temporomandibular Joint Internal Derangement

Keywords

Tenoxicam; ID; PRP; TMD

Outcome Measures

Primary Outcomes (3)

• Intracapsular Pain and pain during movement

  Pain intensity will be measured by VAS score. Zero score for no pain and 10 score for worst pain experienced

  at 1 week, 4, 12, and 24 weeks

• Clicking sound

  Clicking sound will be assessed as to its presence = 1 or absence =0.

  at 1 week, 4, 12, and 24 weeks

• Maximum inter-incisal opening (MIO)

  Maximum inter-incisal opening (MIO): was measured by Vernier caliper as the vertical distance in millimeters between the maxillary and mandibular incisal edges of the central incisors.

  at 1 week, 4, 12, and 24 weeks

Secondary Outcomes (1)

• Magnetic Resonance Imaging (MRI) evaluation

  will be done at 24 weeks postoperatively

Study Arms (2)

patients will receive a mixture of tenoxicam and HA.

EXPERIMENTAL

The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position A mixture of 1mm of TX and 1ml of HA will be slowly injected intra-articular at the point of entry.

Drug: Tenoxicam Injectable Product; Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly

patients will receive a mixture of PRP and HA.

EXPERIMENTAL

10 ml of the patient's blood from the ulnar vein into a sterile glass tube containing sodium citrate as an anticoagulant. After mixing the blood with the citrate, using rotating movements, the tubes will be centrifuged at 1500 rpm for 6 min.The injection point will be marked Patients will be instructed to open their mouths widely and maintain the mandible in a protruded position mixture of 1-ml of PRP and 1-ml of HA will be slowly injected intra-articular at the point of entry.

Drug: Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly

Interventions

Tenoxicam Injectable Product DRUG

(EPICOTIL® Tenoxicam 20 mg , Manufactured by: EGYPTIAN INTERNATIONAL PHARMACEUTICAL INDUSTRIES COMPANY, ReStore at a temperature not exceeding 30°C.)

patients will receive a mixture of tenoxicam and HA.

Hyaluronic Acid 20 MG/1 ML Injection Gel/Jelly DRUG

\* (Hyalubrix® hyaluronic acid sodium salt 30 MG/2 ML, manufactured by Fidia SPA,Italy, stored at temperature \> 25 °C)

patients will receive a mixture of PRP and HA.; patients will receive a mixture of tenoxicam and HA.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age must be (18 -45).
• Patients have painful joint, clicking sound, with or without limited mouth opening.
• patients are unresponsive to conservative treatment.
• Patient's ability and desire to complete the treatment protocol and follow-up visits.
• Patients with internal derangement with reduction confirmed by MRI imaging.

You may not qualify if:

• Patient with an inflammatory or connective tissue disease
• Patient with previous invasive TMJ surgical procedure.
• Neurologic disorders
• History of injection of any substance into the target TMJ during previous 6 months.
• History of drug allergy.
• Patient with a history of bony or fibrous adhesion.
• Malignant disease in the head and neck region.
• TMJ Internal derangement without reduction.
• Patients respond to conservative treatment. 10.Patient with a psychological problem
• Patients having gross mechanical restrictions and condylar fracture

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, 35511, Egypt

Location

Related Publications (20)

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• Talu GK, Ozyalcin S, Koltka K, Erturk E, Akinci O, Asik M, Pembeci K. Comparison of efficacy of intraarticular application of tenoxicam, bupivacaine and tenoxicam: bupivacaine combination in arthroscopic knee surgery. Knee Surg Sports Traumatol Arthrosc. 2002 Nov;10(6):355-60. doi: 10.1007/s00167-002-0306-y. Epub 2002 Aug 7.

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• Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.

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MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Sally Awad, Prof

  Professor of Oral and Maxillofacial Surgery Faculty of Dentistry - Mansoura University

  PRINCIPAL INVESTIGATOR

• Amira Attia, Dr

  Lecturer of Oral and Maxillofacial Surgery Faculty of Dentistry- Mansoura University

  STUDY DIRECTOR

• Manar Mansour, Dr

  Lecturer of Diagnostic and Interventional Radiology Faculty of Medicine- Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: February 20, 2024
• Primary Completion: October 20, 2024
• Study Completion: November 20, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

EG (1)