Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06207955
Other study ID # 23122023
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date May 2025

Study information

Verified date January 2024
Source Fayoum University
Contact Ahmed T Ahmed, Dentist
Phone 1006325722
Email at1219@fayoum.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 39
Est. completion date May 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TMJ 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
TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin
TMJ Arthrocentesis I-PRF Intra-articular Injection
TMJ Arthrocentesis
TMJ Arthrocentesis By Saline

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fayoum University

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Mouth Opening Maximum 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 . 6 months
Secondary Clicking Joint 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 6 months
Secondary Lateral movement Range 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 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05510336 - Assessment of Concentric Needle Technique in Temporomandibular Joint (TMJ) Internal Derangement. N/A
Not yet recruiting NCT02960048 - Clinical Evaluation of Stabilizing Splint (Michigan-type Occlusal Splint) Versus Anterior Repositioning Splint . N/A
Recruiting NCT05627830 - Ultrasound Guided Versus Non-Guided Prolotherapy for Internal Derangement of Temporomandibular Joint. N/A
Recruiting NCT03737305 - RCT of a Temporomandibular Joint Distraction Device for Patients With Articular Disorders Diagnosis N/A
Completed NCT05548894 - Comparison Between Splint and Laser in Patients Without Disc Displacement With Reduction N/A
Completed NCT05481268 - Kinesiotaping and Stretching on SKM and Upper Trapezius Muscle in TMD Patients N/A
Completed NCT06013059 - A Comparative Study Between the Different Levels of TMJ Arthroscopy in the Management of TMJ Internal Derangement N/A
Recruiting NCT06426199 - Chitosan-Hyaluronate Gel Mixture Vs Hyaluronic for Internal Derangement Phase 4
Completed NCT04942743 - Clinical & MRI Finding of TMJ Disk Perforation
Completed NCT04951895 - Clinical and MRI Finding of The Temporomandibular Joint Posterior Disk Displacement
Completed NCT04951830 - Clinical and MRI Finding of The Temporomandibular Joint Stuck Disk
Not yet recruiting NCT03000790 - Evaluation Lingual Ring Splint N/A
Not yet recruiting NCT02992379 - Clinical Evaluation of Stabilizing Splint Versus Pivot Splint as Jaw Exercise Together With Stabilizing Splint N/A
Withdrawn NCT04033692 - MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ
Recruiting NCT05983653 - Evaluation of Arthrocentesis With and Without PRP Injection in Patients With Disc Displacement With Reduction. N/A
Recruiting NCT06441279 - Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials N/A