Clinical trial · Interventional
Effects of Mouth-opening Training on the Maximum Interincisal Opening
Effects of Mouth-opening Training With Follow-up Telephone Calls on the Maximum Interincisal Opening and Mandibular Function of Postoperative Oral Cancer Patients: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PURPOSE:The purpose of the study was to investigate the effect of mouth-opening training with follow-up telephone calls for reducing postoperative trismus in patients with oral cancer. METHODS:The study is a randomized clinical trial using repeated measures. Sixty-eight patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited and randomly assigned to either the intervention or control group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months. Subjects in the intervention group received additional 6 follow-up phone calls to enhance mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one-month, and three-months after discharge, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The mouth-opening training with follow-up telephone calls program | Behavioral | — | UNRESOLVED |
| The mouth-opening training without follow-up telephone calls program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The intervention group
- description
- Subjects in the intervention group received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
- interventionNames
- Behavioral: The mouth-opening training with follow-up telephone calls program
- type
- ACTIVE_COMPARATOR
- label
- The control group
- description
- Subjects in the control group also received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
- interventionNames
- Behavioral: The mouth-opening training without follow-up telephone calls program
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. aged 18 years or older 2. diagnosed with oral cancer 3. scheduled for a primary curative oral cancer surgery 4. able to communicate in Mandarin or Taiwanese 5. obtained medical clearance from the patient's attending physician to participate in the study Exclusion Criteria: 1. diagnosed with lip or tongue cancers which were less relevant to trismus 2. had central incisors extracted during the surgery
References
Publications (4)
- BACKGROUNDWetzels JW, Merkx MA, de Haan AF, Koole R, Speksnijder CM. Maximum mouth opening and trismus in 143 patients treated for oral cancer: a 1-year prospective study. Head Neck. 2014 Dec;36(12):1754-62. doi: 10.1002/hed.23534. Epub 2014 Jan 30. PMID 24478217
- BACKGROUNDKamstra JI, van Leeuwen M, Roodenburg JLN, Dijkstra PU. Exercise therapy for trismus secondary to head and neck cancer: A systematic review. Head Neck. 2017 Nov;39(11):2352-2362. doi: 10.1002/hed.24859. Epub 2017 Jul 14. PMID 29044879
- BACKGROUNDChen M, Li P, Lin F. Influence of structured telephone follow-up on patient compliance with rehabilitation after total knee arthroplasty. Patient Prefer Adherence. 2016 Mar 3;10:257-64. doi: 10.2147/PPA.S102156. eCollection 2016. PMID 27042020
- BACKGROUNDAgarwal P, Shiva Kumar HR, Rai KK. Trismus in oral cancer patients undergoing surgery and radiotherapy. J Oral Biol Craniofac Res. 2016 Nov;6(Suppl 1):S9-S13. doi: 10.1016/j.jobcr.2016.10.004. Epub 2016 Oct 22. PMID 27900243