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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07373730
Enrollment
30
Registered
2026-01-28
Start date
2023-08-10
Completion date
2025-07-31
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disc Displacement

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.

Detailed description

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.

Interventions

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.

OTHERI-PRF

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

Sponsors

Suez Canal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. patients aged from 18 to 40 years old. 2. patients diagnosed with internal derangement of TMJ, suffering from limited mandibular movements, joint pain and clicking. 3. Patients who are free from any systemic disease (ASA I).

Exclusion criteria

1. Patients who have myofascial pain dysfunction syndrome only. 2. Patients who have previous surgery in TMJ. 3. Patients who have previous arthrocentesis within 1 year. 4. Patients with prosthetic joint replacement. 5. Patients allergic to any components of the injecting solution. 6. Patients who received previous trauma to the joint.

Design outcomes

Primary

MeasureTime frameDescription
Maximum mouth openingimmediate preoperative then 1, 3 and 6 months postoperativelywas 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.
Lateral to Right movementimmediate preoperative then 1, 3 and 6 months postoperativelywas 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.
Lateral to Left movementimmediate preoperative then 1, 3 and 6 months postoperativelywas 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.
Protrusive movementimmediate preoperative then 1, 3 and 6 months postoperativelywas 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.
Joint Clickingimmediate preoperative then 1, 3 and 6 months postoperativelywas measured in terms as present or absent by hearing and palpation over each joint during opening and closing jaw movements.
Joint Painimmediate preoperative then 1, 3 and 6 months postoperativelywas measured in a score from 0 to 10 using the visual analogue scale \[VAS\] over the TMJ area. \[ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain\].

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026