NCT05227807

Brief Summary

PURPOSE: The purpose of the study was to investigate the efficacy of mouth-opening training with follow-up on 1st、3rd、6th months for reducing postoperative trismus in patients with oral cancer. METHODS: The study is a quasi-experimental design using repeated measures. 44 patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited to the control group first then 38 patients were recruited to the intervention group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months and two telephone calls fellow up. Subjects in the intervention group received mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one month, three months, and six months after radiotherapy, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire, Restriction of Mouth Opening Questionnaire, and Difficulty of Food Intake.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2014

Completed
7 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 7, 2022

Completed
Last Updated

February 7, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

December 12, 2021

Last Update Submit

February 2, 2022

Conditions

Head and Neck Neoplasms

Keywords

oral cancerTrismusMouth-opening trainingMaximum interincisal openingFollow-up telephone callsMandibular function

Outcome Measures

Primary Outcomes (1)

  • MIO( Maximum inter-incisal opening)

    With the disposable oral activity scale (The TheraBite Range-of-Motion Scales), patients are asked to open their mouths as wide as possible while sitting on a chair. The TheraBite Range-of-Motion Scale was used to measure MIO with the subject in an upright position. Subjects with MIO \<35 mm were considered to have trismus. The scale was measured by mm. For all values of mouth opening from 20 to 50 mm.The higher the score, the mouth is open.

    Change from pre-intervention and during the intervention on 2, 4, and 6 months

Secondary Outcomes (3)

  • Restriction of Mouth Opening Questionnaire

    Change from pre-intervention and during the intervention on 2, 4, and 6 months

  • Mandibular Function Impairment Questionnaire

    Change from pre-intervention and during the intervention on 2, 4, and 6 months

  • Exercise Time

    each week during the intervention

Study Arms (2)

Control group

ACTIVE COMPARATOR

the control group received routine care.

Behavioral: Usual care

Intervention group

EXPERIMENTAL

Intervention develop from the theoretical framework of social cognition theory

Behavioral: mouth opening exercise

Interventions

mouth opening exerciseBEHAVIORAL

The intervention group receives an oral exercise intervention, including a 30-minute individual training, a multimedia oral exercise education video along with a print education booklet, and three follow-up phone calls.

Intervention group
Usual careBEHAVIORAL

routine care including written mouth exercise instructions

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old
  • have a clear consciousness
  • can communicate in Mandarin and Taiwanese
  • diagnosed by a doctor as primary oral cancer (including gums, the floor of the mouth, buccal mucosa, hard palate, and posterior molar area) and
  • undergoing oral cancer tumor resection (including upper lymphatic removal) Those who have undergone skin flap reconstruction
  • radiation and/or concurrent chemotherapy.

You may not qualify if:

  • Poor wound healing after surgery and unable to perform the oral movement
  • no incisor or the position of the incisor after surgery is replaced by a flap due to surgery, the maximum opening distance cannot be measured
  • those with lip and tongue cancers that are less related to the closure of the teeth ( Or those who are physically unable to exercise)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsMouth NeoplasmsTrismus

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • SuFan Wu, Doctor

    National Taipei University of Nursing and Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 12, 2021

First Posted

February 7, 2022

Study Start

July 7, 2012

Primary Completion

October 30, 2014

Study Completion

December 12, 2014

Last Updated

February 7, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share