Pilotstudy: application of botulinumtoxin A (Xeomin®) to investigate the efficacy and safety of NT 201 for the prophylaxis of relapse after advancement of the mandible
- Conditions
- The study will analyse the efficacy of BTX-A to avoid a relapse after advancement of the mandible (BSSO – bilateral sagittal split osteotomy) with more than 5 mm. The tension of the muscle complex of the anterior floor of the mouth can cause a relapse of the advancement of the mandible in the follow up.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2011-003646-41-AT
- Lead Sponsor
- Oliver Ploder MD, DDS, PhD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Female or male individuals with mandibular retrognathia, aged = 18 complying with the following main inclusion criteria:
- mandibular retrognathia with more than 5 mm discrepancy, measured via standardized x-ray and measurement methods for orthognathic surgery
- not allergic against BTX-A
- no muscle diseases (eg Myasthenia gravis, Lambert-Eaton-Syndrom) or muscle atrophy
- no infection at the localization of injection
- no taking of anticoagulations
- no pregnancy or breast feeding
- no dysphagia
- written consent
- fully capable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
If patients do not meet inclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method