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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-05-31

Brief Summary

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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 .

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Detailed Description

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Conditions

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TMJ Disc Disorder TMJ Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin

Intervention Type DRUG

TMJ Arthrocentesis I-PRF Intra-articular Injection

TMJ arthrocentesis

Group Type ACTIVE_COMPARATOR

TMJ Arthrocentesis

Intervention Type DRUG

TMJ Arthrocentesis By Saline

Interventions

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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

Intervention Type DRUG

TMJ Arthrocentesis Followed By Injectable Platelet Rich Fibrin

TMJ Arthrocentesis I-PRF Intra-articular Injection

Intervention Type DRUG

TMJ Arthrocentesis

TMJ Arthrocentesis By Saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No