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

Pilotstudy: randomized, open label, single-center study to investigate the efficacy and safety of NT 201 for the prophylaxis of relapse after advancement of the mandible

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003646-41-AT

Enrollment

Unknown

Registered

2011-11-24

Start date

2011-11-30

Completion date

Unknown

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Xeomin Product Name: Xeomin Pharmaceutical Form: Powder for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: If patients do not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary efficacy variable is the percentage of responders during the study. A responder is defined as: Somebody whose SNB angle between first postoperative and following postoperative radiograph is < 1° (corresponds to less than 1.7 mm relapse). SNB Angle: Sella – Nasion – B-Point Angle. The difference will be measured on standardized radiographs (lateral cephalogram at 1.5 m distance) between first postoperative radiograph (2-3 days postoperatively) and the subsequent radiographs (6, 12 and 24 months postoperatively). In all 3 controls the data has to meet the benchmarks of a responder, otherwise it will be counted as a relapse.;Secondary Objective: All secondary variables (changes in SNB angle etc. ) will be analyzed descriptively. ;Primary end point(s): Investigation of the SNB angle at each visit;Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of this endpoint difference between 1st week and 6 weeks after surgery and 6, 12 and 24 months after surgery will be measured on standardized radiographs	—

Measure

Time frame

Main Objective: The primary efficacy variable is the percentage of responders during the study. A responder is defined as: Somebody whose SNB angle between first postoperative and following postoperative radiograph is < 1° (corresponds to less than 1.7 mm relapse). SNB Angle: Sella – Nasion – B-Point Angle. The difference will be measured on standardized radiographs (lateral cephalogram at 1.5 m distance) between first postoperative radiograph (2-3 days postoperatively) and the subsequent radiographs (6, 12 and 24 months postoperatively). In all 3 controls the data has to meet the benchmarks of a responder, otherwise it will be counted as a relapse.;Secondary Objective: All secondary variables (changes in SNB angle etc. ) will be analyzed descriptively. ;Primary end point(s): Investigation of the SNB angle at each visit;Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of this endpoint difference between 1st week and 6 weeks after surgery and 6, 12 and 24 months after surgery will be measured on standardized radiographs

—

Secondary

Measure	Time frame
Secondary end point(s): All secondary variables (changes in SNB angle, distance pogonion to postgonion, distance gnathion to condylon, post airway space, muscle belly) will be analyzed descriptively. ;Timepoint(s) of evaluation of this end point: at the same timepoints as the primary end point	—

Countries

Austria

Contacts

Public ContactLKH Feldkirch

Oliver Ploder MD, DDS, PhD

oliver.ploder@lkhf.at+435522 303 15 01

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026