Evaluation of the Efficacy of Injectable Platelet-Rich Fibrin Mixed With Hyaluronic Acid in Treatment of Temporomandibular Joint Internal Derangement

NCT07373730 | Completed

• 1 other identifier: 2023/667
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

we inject I-PRF and Hyaluronic Acid inside the human TMJ with internal derangement after arthrocentesis, and follow-up is made to evaluate the effect of this treatment.

Conditions

Temporomandibular Joint Disc Displacement

Outcome Measures

Primary Outcomes (6)

• Maximum mouth opening

  was measured in millimeters using a ruler or digital caliper. It is the vertical distance between the incisal edges of upper and lower central incisors at maximum opening while the patients were instructed to set in an upright position in a dental chair.

  immediate preoperative then 1, 3 and 6 months postoperatively

• Lateral to Right movement

  was measured in millimeters using a ruler or digital caliper. It is the horizontal distance between the maxillary and the mandibular midlines with the teeth slightly separated and the mandible moved towards the right side.

  immediate preoperative then 1, 3 and 6 months postoperatively

• Lateral to Left movement

  was measured in millimeters using a ruler or digital caliper. It is the horizontal distance between the maxillary and the mandibular midline with the teeth slightly separated and the mandible moved towards the left side.

  immediate preoperative then 1, 3 and 6 months postoperatively

• Protrusive movement

  was measured in millimeters using a ruler or digital caliper. It is the distance from midpoint of incisal edge of maxillary incisors to midpoint of incisal edge of the mandibular incisors during mandibular protrusion.

  immediate preoperative then 1, 3 and 6 months postoperatively

• Joint Clicking

  was measured in terms as present or absent by hearing and palpation over each joint during opening and closing jaw movements.

  immediate preoperative then 1, 3 and 6 months postoperatively

• Joint Pain

  was measured in a score from 0 to 10 using the visual analogue scale \[VAS\] over the TMJ area. \[ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain\].

  immediate preoperative then 1, 3 and 6 months postoperatively

Study Arms (2)

study group

ACTIVE COMPARATOR

Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe; Other: I-PRF

control group

ACTIVE COMPARATOR

Drug: Hyalgan 20 mg in 2 ML Prefilled Syringe

Interventions

Hyalgan 20 mg in 2 ML Prefilled Syringe DRUG

For the control group: 1mm of the drug was injected into the joint. For the study group: 0.5mm of the drug was injected into the joint.

control group; study group

I-PRF OTHER

Only given for the study group: 0.5mm of I-PRF was injected into the joint.

study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients aged from 18 to 40 years old.
• patients diagnosed with internal derangement of TMJ, suffering from limited mandibular movements, joint pain and clicking.
• Patients who are free from any systemic disease (ASA I).

You may not qualify if:

• Patients who have myofascial pain dysfunction syndrome only.
• Patients who have previous surgery in TMJ.
• Patients who have previous arthrocentesis within 1 year.
• Patients with prosthetic joint replacement.
• Patients allergic to any components of the injecting solution.
• Patients who received previous trauma to the joint.

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 28, 2026
• Study Start: August 10, 2023
• Primary Completion: June 20, 2024
• Study Completion: July 31, 2025
• Last Updated: January 28, 2026

Record last verified: 2025-10

Locations

EG (1)