NCT03875118

Effects of Mouth-opening Training on the Maximum Interincisal Opening

Completed NA Results posted Last updated 27 April 2021

What this trial tests

NA trial testing The mouth-opening training with follow-up telephone calls program in Oral Cancer in 68 participants. Completed in 31 March 2014.

Timeline

18 June 2012

Primary endpoint
31 March 2014

31 March 2014

Quick facts

Lead sponsor	National Taipei University of Nursing and Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	68
Start date	18 June 2012
Primary completion	31 March 2014
Estimated completion	31 March 2014
Sites	1 location across Taiwan

Drugs / interventions tested

• The mouth-opening training with follow-up telephone calls program
• The mouth-opening training without follow-up telephone calls program

Conditions studied

• Oral Cancer — all drugs for Oral Cancer →

Sponsor

National Taipei University of Nursing and Health Sciences

Who can join

18 and older, any sex, with Oral Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

TheraBite Range-of-Motion Scale Primary · Change from Baseline to 3 months

The TheraBite® Range-of-Motion Scale was used to measure the maximum incisal opening (MIO), which is the maximal vertical distance between the edges of the incisors of the maxilla and the mandible. The TheraBite® Range-of-Motion Scale is a disposable paper measuring scale specially designed to measure a subject's mouth and jaw opening. The subject sits in an upright position with his mouth open wide. For measuring the vertical opening, the scale has a possible range of 5 to 70 mm, with the notch is placed on the lower incisor midline. The usual range of MIO is between 40 and 55 mm. Subjects wi

Baseline

Group	Value	95% CI
Mouth-opening Training With Follow-up Calls	27.43	± 10.71
Mouth-opening Training Without Follow-up Calls	26.57	± 10.53

3 month later

Group	Value	95% CI
Mouth-opening Training With Follow-up Calls	27.33	± 9.73
Mouth-opening Training Without Follow-up Calls	16.17	± 8.01

Mandibular Function Impairment Questionnaire (MFIQ) Secondary · Change from Baseline to 3 months

The MFIQ (Mandibular Function Impairment Questionnaire) was used to measure the extent of patients' mandibular function impairment. The questionnaire consists of 17 items, each of which targets a specific oral function impairment; including difficulties in social activity, speech, taking a large bite, chewing hard food, chewing soft food, work and/or daily activities, drinking, laughing, chewing resistant food, yawning, kissing, and eating different types of food. The subjects were asked to indicate how much difficulty they had with each activity or with eating each type of food using a 5-poin

Baseline

Group	Value	95% CI
Mouth-opening Training With Follow-up Calls	0.16	± 0.21
Mouth-opening Training Without Follow-up Calls	0.17	± 0.20

3 month later

Group	Value	95% CI
Mouth-opening Training With Follow-up Calls	0.18	± 0.23
Mouth-opening Training Without Follow-up Calls	0.55	± 0.30

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.