N/A N=68 Randomized Double-blind Supportive Care

Effects of Mouth-opening Training on the Maximum Interincisal Opening

Oral Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03875118 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: TheraBite Range-of-Motion Scale — 27.43; 26.57; 27.33; 16.17 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: The mouth-opening training with follow-up telephone calls program (Behavioral); The mouth-opening training without follow-up telephone calls program (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Taipei University of Nursing and Health Sciences
Primary completion: Mar 2014

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	—

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.

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

View full record on ClinicalTrials.gov →

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.