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I-PRF After Arthrocentesis Plus Botox Injection to Lateral Pterygoid Muscle in Treatment of Anterior Disc Displacement

Does Intra-articular Injection of Platelet-Rich Fibrin After Arthrocentesis Followed by Lateral Pterygoid Muscle Injection With Botulinum Toxin Type A Improve Clinical Outcomes for Anterior Disc Displacement?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06207955
Enrollment
39
Registered
2024-01-17
Start date
2024-01-18
Completion date
2025-09-11
Last updated
2026-09-01

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

Conditions

TMJ Disc Disorder, TMJ Pain

Keywords

Anterior Disc Displacement, TMJ Clicking, I-PRF, Lateral Pterygoid Muscle, Arthrocentesis, Botulinum Toxin Type A

Brief summary

Aim of Study : To evaluate the efficacy of TMJ arhtrocentesis followed by injection of liquid platelet rich fibrin (I-PRF ) in addition to intramuscular injection of lateral pterygoid muscle with botulinum toxin on clinical outcomes of painful TMJ , maximum mouth opening , joint sounds and range of lateral movement in patients with TMJ anterior disc displacement with reduction Hypothesis : Intramuscular injection of lateral pterygoid muscle with botulinum toxin plus TMJ intra-articular injection of liquid platelet rich fibrin after arthrocentesis are more effective than TMJ arthrocentesis followed by intra-articular injection of ( I-PRF ) or TMJ arthrocentesis only .

Interventions

DRUGTMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A

TMJ Arthrocentesis I-PRF Intra-articular Injection Botulinum Toxin Type A to Lateral Pterygoid Muscle

DRUGTMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin

TMJ Arthrocentesis I-PRF Intra-articular Injection

TMJ Arthrocentesis By Saline

Sponsors

Fayoum University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients with painful tmj during jaw movements * Patients with joint sounds ( clicking ) during jaw opening and mastication * Patients age range from 16 years old to 45 years old * Patients with Class I maxillo-mandibular relationship * Patients with reduced mouth opening * All patients diagnosed clinically and radiographically by MRI as TMJ anterior disc displacement with reduction

Exclusion criteria

* Patient with history of recent trauma * Patients with malocclusion * Patients with systematic condition that affect bone and joints such as osteoarthritis , systemic lupus and epilepsy . * Patients allergic to botox injection * Pregnant or lactating females * Patients with non-reducible disc on MRI * Patients contraindicated to exposure to MRI * Patients with previous tmj arthrocentesis , arthroscopy or TMJ surgery * Significant mechanical obstruction that prevents mouth opening, acute capsulitis, benign or malignant temporomandibular joint lesions. * Patients with blood diseases, and coagulation disorders

Design outcomes

Primary

MeasureTime frameDescription
Maximum Mouth Opening6 monthsMaximum mouth opening will be measured as the distance from incisal edges of the upper and lower central incisors using a ruler and will be evaluated preoperatively , immediately after the procedure , 1month , 3 months and 6 months postoperative .

Secondary

MeasureTime frameDescription
Clicking6 monthsJoint sounds also will be evaluated during opening and closing of the jaws and during lateral movements preoperatively , immediately after the procedure , 1 months , 3 months and 6 months postoperative
Lateral movement6 monthsRange of lateral mandibular movement will be measured using Vernier caliper in millimeters as the horizontal distance extending from maxillary midline to mandibular midline by asking the patient to move the mandible to one side then to the other side to maximum extent

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026