N/A
Completed N=68
Effects of Mouth-opening Training on the Maximum Interincisal Opening
Source: ClinicalTrials.gov NCT03875118 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: TheraBite Range-of-Motion Scale — 27.43; 26.57; 27.33; 16.17 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TheraBite Range-of-Motion Scale |
27.43; 26.57; 27.33; 16.17 | — |
| SECONDARY Mandibular Function Impairment Questionnaire (MFIQ) |
0.16; 0.17; 0.18; 0.55 | — |
Eligibility Criteria
Inclusion Criteria
- aged 18 years or older
- diagnosed with oral cancer
- scheduled for a primary curative oral cancer surgery
- able to communicate in Mandarin or Taiwanese
- obtained medical clearance from the patient's attending physician to participate in the study
Exclusion Criteria
- diagnosed with lip or tongue cancers which were less relevant to trismus
- had central incisors extracted during the surgery
Data sourced from ClinicalTrials.gov (NCT03875118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.