Status:

COMPLETED

Comparison of Temporomandibular Joint Arthroscopy With Botulinum Toxin Injection Versus Placebo

Lead Sponsor:

Instituto Portugues da Face

Conditions:

Temporomandibular Joint Disorders

Eligibility:

All Genders

12-60 years

Phase:

PHASE4

Brief Summary

There are several studies that have considered Botulinum toxin A (BoNT-A) injections are effective in treating symptoms for Temporomandibular Joint (TMJ) disorders. BoNT-A injections improve the hyper...

Detailed Description

Study Objective: To investigate the potential performance of incobotulinumtoxin-A (BTXA) in patients submitted to TMJ surgical arthroscopy. Besides the acceptable good outcomes of TMJ arthroscopy, th...

Eligibility Criteria

Inclusion

  • Patients with TMJ with indication for arthroscopy
  • Age between 12-60 years old
  • Minimum level of pain for inclusion should be 5/10 (on a 0-10 VAS scale)

Exclusion

  • Previous treatment to TMD
  • Previous use of facial Botulinum Toxin
  • Any contraindication for the use of BTXA according to XEOMIN SmPC

Key Trial Info

Start Date :

January 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2022

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT04810429

Start Date

January 1 2021

End Date

June 1 2022

Last Update

October 21 2022

Active Locations (1)

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Instituto Português da Face

Lisbon, Portugal, 1050-227