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

NCT06207955 | Unknown

• 1 other identifier: 23122023
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/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 .

Conditions

TMJ Disc Disorder; TMJ Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clicking

  6 months

• Lateral movement

  6 months

Study Arms (3)

TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle

ACTIVE COMPARATOR

Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin And Botulinum Toxin Type A

TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF )

ACTIVE COMPARATOR

Drug: TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin

TMJ arthrocentesis

ACTIVE COMPARATOR

Drug: TMJ Arthrocentesis

Interventions

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

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

TMJ arthrocentesis + (I-PRF) injection & injection of Botox to lateral pterygoid muscle

TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin DRUG

TMJ Arthrocentesis I-PRF Intra-articular Injection

TMJ arthrocentesis followed by intra-articular injection of liquid platelet rich fibrin ( I-PRF )

TMJ Arthrocentesis DRUG

TMJ Arthrocentesis By Saline

TMJ arthrocentesis

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fayoum University: lead

MeSH Terms

Interventions

Botulinum Toxins, Type A; Arthrocentesis

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ahmed T Ahmed, Dentist

CONTACT

1006325722; at1219@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master student of oral and maxillofacial surgery

Study Record Dates

• First Submitted: December 23, 2023
• First Posted: January 17, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: May 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01