Improvement of the discomfort of the paresthesia, as experienced by the patient.
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Improvement of the discomfort of the paresthesia, as experienced by the patient
after 3 months..
Secondary outcome
Improvement of the results of the neuro-sensibility tests after 3 months.
Improvement of sensibility, as experienced by the patient, after 3 months
Mean difference in discomfort after 6 months.
Mean difference in the results of the neuro-sensibility tests after 6 months.
Mean difference of sensibility, as experienced by the patient, after 6 months.
Background summary
An advancement procedure of the mandible is a routine operation in oral and
maxillofacial surgery. More than 50 of these procedures are performed in the
Isala Klinieken every year. The mean complication in patients who underwent
this operation is a permanent dysfunction in the inferior alveolar nerve, that
can possibly lead to problems in eating or speaking, due to a lack of
neuro-sensory feedback in the oral region. Incidence rate of this complication
is about 15-20%, which means that 8-10 patients a year experience this
discomfort. Recently, several patients have been treated by a speech therapist
with a significant positive improvement in oral function and a diminished
discomfort from the paresthesia.
In current literature there is no data available on this myofunctional therapy,
therefore, this promising new treatment option needs to be evaluated in a
clinical trial.
Study objective
Improvement of the discomfort of the paresthesia, as experienced by the
patient.
Study design
Study design is a parallel randomized study. Randomization will take place
after informed consent by the patients. Patients allocated for speech therapy
will receive 5 sessions of therapy for 10 weeks. Treatment group will be
evaluated before start of treatment, at the end of treatment and after 3
months. The control group will start therapy after 3 months and will be
evaluated at the start of the control period, after 3 months at the end of the
control period (start of treatment) and after 6 months at the end of therapy.At
these time points, each patients will receive a VAS score questionnaire and
will be subjected to neuro-sensibility tests.
Study burden and risks
Minimal, only 5 therapy sessions with the speech therapist and 3 evaluations.
Groot Wezenland 20
8000GM Zwolle
NL
Groot Wezenland 20
8000GM Zwolle
NL
Listed location countries
Age
Inclusion criteria
- BSSO or DOG procedure, after orthodontic treatment.
- Paresthesia of the inferior alveolar nerve, present for more than one year.
Exclusion criteria
- Pre-existing dysfunction of the inferior alveolar nerve.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL23638.075.08 |