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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Suez Canal University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Maximum mouth opening
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
study group
Intervention: Hyalgan 20 mg in 2 ML Prefilled Syringe (Drug)
study group
Intervention: I-PRF (Other)
control group
Intervention: Hyalgan 20 mg in 2 ML Prefilled Syringe (Drug)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
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. \[ 0 is given when there is no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, 10 the worst pain\].
Secondary Outcomes
No secondary outcomes reported