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NCT Number: NCT07373730

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

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.

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Key information

Conditions

Temporomandibular Joint Disc Displacement

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Suez Canal University

Ismailia, Egypt

About this study

This study was made to evaluate the efficacy of injectable Platelet Rich Fibrin (I-PRF) with Hyaluronic Acid (HA) injection after arthrocentesis in treatment of Temporomandibular joint Internal Derangement.

The study was conducted on 30 patients whose ages ranged from 18 to 40 years, presented with impaired jaw function, limited mouth opening, Pain during joint movement and clicking. TMJ internal derangement was verified by preoperative MRI.

Patients with MPDS only, systemic debilitating disease, previous surgery in the TMJ, previous arthrocentesis, previous trauma to the joint were excluded from the study.

Control group: 15 cases were treated by arthrocentesis then injection of 1ml of Hyaluronic acid (HA).

Study group: 15 cases were treated by arthrocentesis then injection of 0.5ml of Hyaluronic acid (HA) and 0.5ml of injectable platelet rich fibrin (I-PRF).

Clinical assessment of pain by VAS, clicking as present or not, maximum mouth opening in millimeters, right and left lateral movements and protrusive movements was done preoperatively and postoperatively at 1,3,6 months.

MRI assessment was done preoperatively and 6 months postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

I-PRF

Other

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

Primary outcomes

  1. Maximum mouth opening

    Time frame: immediate preoperative then 1, 3 and 6 months postoperatively

    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.

  2. Lateral to Right movement

    Time frame: immediate preoperative then 1, 3 and 6 months postoperatively

    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.

  3. Lateral to Left movement

    Time frame: immediate preoperative then 1, 3 and 6 months postoperatively

    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.

  4. Protrusive movement

    Time frame: immediate preoperative then 1, 3 and 6 months postoperatively

    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.

  5. Joint Clicking

    Time frame: immediate preoperative then 1, 3 and 6 months postoperatively

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

  6. Joint Pain

    Time frame: immediate preoperative then 1, 3 and 6 months postoperatively

    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].

Sponsors and collaborators

Lead sponsor

Suez Canal University

Other

Registry information

Official study title

Clinical and Radiographic Evaluation of the Efficacy of Injectable Platelet Rich Fibrin Mixed With Hyaluronic Acid in Treatment of Temporomandibular Joint Internal Derangement: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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