Effects of Dynasplint Trismus System® excercises compared to TheraBite® Jaw Motion Rehabilitation System* exercises on mouth opening in patients with trismus secondary to head and neck cancer; a randomized controlled trial.

Effects of Dynasplint Trismus System® excercises compared to TheraBite® Jaw Motion Rehabilitation System* exercises on mouth opening in patients with trismus secondary to head and neck cancer; a randomized controlled trial. - Exercise therapy for trismus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44141

Enrollment

Registered

2016-01-14

Start date

2016-06-30

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

aandoeningen het aan kauwstelsel restricted mouth opening trismus

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Effects of exercise therapy as change in mouth opening (millimetres)	—

Secondary

Measure	Time frame
Experienced pain, limitations of mandibular function, quality of life, and patient satisfaction of stretching device.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)