Methods
Patients in this randomized controlled study, comparing
a daily self-administered home-based facial
exercise therapy and a supervised rehabilitation
technique for the treatment of postoperative facial
dysfunction after conventional superficial parotidectomy,
were recruited from the Department of Oral
and Maxillofacial Surgery in Virgen del Rocio
University Hospital (Seville, Spain) between
January 2008 and December 2010. The inclusion
criteria were applied: age up to 18 years with a
pleomorphic adenoma located in the supra-facial
area of the parotid gland newly diagnosed by CT/
MRI and fine needle aspiration. The following
exclusion criteria were applied: previous surgery on
the affected parotid gland, history of idiopathic
facial paralysis or other cause, serious mental illness
or social problems, and neurological disorders.
Before the surgical operation, the study eligible
participants were randomized into a control group
or an experimental group. A random number table
with group allocation was computer-generated by a
statistician who was not working with the patients.
These allocations were placed in sealed masked
envelopes with a specific number. The study protocol
was approved by the Ethics Committee of the
Virgen del Rocio University Hospital (approval
credential 03/06) and all patients gave informed
consent to participate.
All patients underwent a conventional superficial
parotidectomy with facial nerve dissection.
The surgical procedure remained identical in all
cases. A conventional superficial parotidectomy
with antegrade dissection of the main trunk and all
the peripheral branches of the facial nerve was performed.
All facial nerve branches were preserved.
Nerve stimulation was not used for nerve location.
In all cases, resection of the pleomorphic adenoma
together with the superficial lobe of the parotid
gland was carried out.
One week after operation, each patient met with
an independent observer (EGC) for the first control
visit at the outpatient surgery clinic. The observer
checked that after surgery each patient still met the
criteria for inclusion and exclusion, and then
opened the specific numbered envelope that
revealed each patient´s allocation to control or