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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1
Instituto Português da Face
Lisbon, Portugal, 1050-227