To compare the effects of exercise therapy on mouth opening using the TheraBite and the DTS in a randomized controlled trial in head and neck cancer patients suffering from trismus.
ID
Source
Brief title
Condition
- Other condition
- Tendon, ligament and cartilage disorders
- Miscellaneous and site unspecified neoplasms benign
Synonym
Health condition
aandoeningen het aan kauwstelsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effects of exercise therapy as change in mouth opening (millimetres)
Secondary outcome
Experienced pain, limitations of mandibular function, quality of life, and
patient satisfaction of stretching device.
Background summary
The incidence of head and neck cancer was 17.69 per 100,000 persons in 2013 in
the Netherlands with a total of 2964 head and neck cancer subjects in 2013. The
mortality of head and neck cancer was 5.23 per 100,000 persons with a total of
875 subjects in 2013. The survival rates differ strongly per tumour
localization. Head and neck cancer subjects often suffer from xerostomia (5%),
a severely restricted mouth opening (48%) and reduced mobility of the tongue
(46%) after cancer treatment. The prevalence of a severely restricted mouth
opening of 35 millimetres or less, also known as trismus, ranges from 5% to
46%. Trismus may be caused by tumour infiltration in the head and neck area, or
treatment of the tumour itself consisting of surgery, radiotherapy,
chemotherapy or a combination of these modalities. Trismus reduces mandibular
functioning and quality of life. Trismus can impair speech, oral hygiene,
dental treatment, airway clearance, and oncological follow-up. Therefore,
increase of the mouth opening is of important for subjects, as well as for the
dentist of oncological professional.
To increase mouth opening, a variety of exercise therapies exist. Simple
exercises using tongue blades or rubber plugs have only a minor effect on mouth
opening. Exercise therapy with sophisticated stretching devices such as the
TheraBite® Jaw Motion Rehabilitation System* (TheraBite) and the Dynasplint
Trismus System® (DTS) seem to increase mouth opening effectively. The mouth
opening can be increased up to 14 millimetres after exercise therapy using the
TheraBite or the DTS.A head to head comparison of the TheraBite and the DTS
regarding the increase in mouth opening in head and neck cancer subjects
suffering from trismus has not been performed, thus effectiveness of the device
relative to each other has not been investigated.
Study objective
To compare the effects of exercise therapy on mouth opening using the TheraBite
and the DTS in a randomized controlled trial in head and neck cancer patients
suffering from trismus.
Study design
A randomised controlled trial
Intervention
DTS: 1 stretch per session, 3 times a day for 30 minutes. (a total of 90
minutes a day)
TheraBite: 20 stretches per session, 6 times a day, 30 seconds OR 30 stretches
per session, 4 times a day, 30 seconds. (a total of 60 minutes a day)
Study burden and risks
Patients will receive exercise therapy for 3 months, with a follow- up of 3
months. Pain in the head and neck area may occur. Dental trauma may occur when
patients place the stretching device into the mouth or remove the stretching
device too vigorously. Fracture of the jaw may occur.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Patients (1) are at least 18 years, (2) received treatment concerning head and neck cancer (including surgery, radiotherapy and chemotherapy) at the Department of Oral and Maxillofacial Surgery at the UMCG, (3) have a maximal mouth opening of 35 millimeter or less.
Exclusion criteria
Patients diagnosed with osteoporosis or osteonecrosis or severe periodontitis, have oral abscesses or other infectious processes in the head and neck region, have a recurrence or metastases in the head and neck region.
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 | NL54802.042.15 |