No registrations found.
ID
Source
Health condition
trismus
restricted mouth opening
mouth opening
head and neck cancer
head and neck neoplasms
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
Patients treated for head and neck cancer often suffer from several adverse effects after oncological treatment, including a severely restricted mouth opening (trismus). Trismus impacts oral functioning (biting, chewing, laughing, yawning, drinking, kissing etc.) considerably and as a result also quality of life. In this randomized controlled trial, two stretching devices, the TheraBite® Jaw Motion Rehabilitation System™ (TheraBite) and the Dynasplint Trismus System® (DTS), will be compared regarding the increase in mouth opening in head and neck cancer patients with a severely restricted mouth opening. Secondary outcome variables are oral functioning and quality of life.
Study objective
Increase in mouth opening after exercise treatment using the following stretching devices: the TheraBite or Dynasplint.
Study design
week 0, 3, 6, 12, 26.
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
P.U. Dijkstra
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
050 3613651
p.u.dijkstra@umcg.nl
P.U. Dijkstra
Hanzeplein 1
Groningen 9713 GZ
The Netherlands
050 3613651
p.u.dijkstra@umcg.nl
Inclusion criteria
Patients (1) are at least 18 years, (2) received treatment concerning head and neck cancer (including surgery, radiotherapy and chemotherapy) (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 |
|---|---|
| NTR-new | NL4176 |
| NTR-old | NTR5589 |
| Other | 54802 : ABR |