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Investigating the use of the masseteric nerve for the innervation of free functional muscle transfers in facial paralysis

Investigating the use of the masseteric nerve for the innervation of free functional muscle transfers in facial paralysis - SMILE - Spontaneous Muscle Innervation in faciaL rEanimation surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00009899
Enrollment
60
Registered
2016-02-19
Start date
2016-01-13
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Healthy volunteers G51.0

Interventions

Group 1: Facial Reanimation by free functional gracilis muscle transfer with coaptation to the masseteric nerve Group 2: Pre-study: healthy volunteers for detecting co-activation of the masseteric mus

Sponsors

Uniklinik Freiburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients chosing one staged facial reanimation by means of free functional muscle transfer with coaptation to the masseteric nerve. For the prestudy 30 healthy volunteers.

Exclusion criteria

Exclusion criteria: Age under 18, patients undergoing a two-stage procedure using an alternative donor nerve (so called cross face nerve graft), failed facial reanimation surgery in the past.

Design outcomes

Primary

MeasureTime frame
Spontaneous or non-spontaneous smile after facial reanimation Surgery by means of free functional muscle transfer. Analysis in clinical examination 6 months after surgery. In the pre-study: Co-activation of the masseter muscle upon smiling as detected by electromyography.

Countries

Germany

Contacts

Public ContactSteffen Eisenhardt

Uniklinik Freiburg

steffen.eisenhardt@uniklinik-freiburg.de076127028680

Outcome results

None listed

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