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van CCT (UK)

van CCT (UK)

Exercise therapy for trismus

- candidate number23456
- NTR NumberNTR5589
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2015
- Secondary IDsABR 54802
- Public TitleExercise therapy for trismus
- Scientific TitleEffects 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
- hypothesisIncrease in mouth opening after exercise treatment using the following stretching devices: the TheraBite or Dynasplint.
- Healt Condition(s) or Problem(s) studiedTrismus, Head and Neck Squamous Cell Carcinoma
- Inclusion criteriaPatients (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 criteriaPatients 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blinding[default]
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2016
- planned closingdate31-okt-2017
- Target number of participants60
- InterventionsDTS: 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
- Primary outcomeEffects of exercise therapy as change in mouth opening (millimetres)
- Secondary outcomeExperienced pain, limitations of mandibular function, quality of life, and patient satisfaction of stretching device.
- Timepointsweek 0, 3, 6, 12, 26.
- Trial web site
- statusstopped: trial finished
- CONTACT for SCIENTIFIC QUERIESprof. dr. P.U. Dijkstra
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications
- Brief summaryPatients 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.
- Main changes (audit trail)
- RECORD5-dec-2015 - 20-aug-2018

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