Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses

February 1, 2026 updated by: National Taiwan University Hospital
This study investigates mouth cancer patients who use a special plate called an obturator to help them swallow. Tongue strength and biting force will be measured and compared to daily dietary intake. Results will provide a better understanding of how to improve eating ability and overall quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

For oral cancer patients who have undergone maxillectomy, the use of an obturator can help restore partial swallowing function, thereby improving quality of life. Measuring tongue pressure provides insight into the extent of a patient's swallowing function, while occlusal pressure measurement assesses occlusal force, offering guidance for dietary modifications. This study will utilize a tongue pressure measurement device and occlusal pressure Prescale film to quantify tongue elevation pressure and occlusal force in post-maxillectomy oral cancer patients who wear obturators. This will be complemented by questionnaires to understand the participants' daily dietary habits and content. The aim is to establish the distribution of tongue and bite pressures within this patient population and to preliminarily determine the correlation between these pressures and daily diet

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Department of Dentistry of National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The clinical trial will be conducted at the Outpatient Department of Dentistry at National Taiwan University Hospital.

The study subjects will be oral cancer patients who have undergone maxillectomy and wear an obturator. They will be recruited from patients routinely followed up and treated by the principal investigator, or similar patients referred by colleagues within the same department.

Description

Inclusion Criteria:

  • Primary treatment must include maxillectomy, with or without adjuvant chemotherapy or radiotherapy.
  • Age range: 18 to 85 years old (all genders).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Inability to understand the investigator's instructions (or indications).
  • Inability to hold the tongue pressure probe and occlusal pressure Prescale film in the proper position.
  • Inability to apply pressure to the tongue pressure probe and occlusal pressure Prescale film.
  • Dysphagia (difficulty swallowing) resulting from prior head and neck cancer treatment.
  • Severe dysphagia caused by a central nervous system disorder.
  • Presence of temporomandibular joint (TMJ) pain.
  • The investigator determines the patient is unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Maxillectomy patients with obturator prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Tongue Pressure
Time Frame: Baseline

Tongue pressure is measured using the Iowa Oral Performance Instrument (IOPI). The pressure balloon is positioned on either the anterior tongue (behind the anterior alveolar ridge) or the posterior tongue (at the junction of the hard and soft palate). The subject is instructed to press the pressure balloon firmly with their tongue for a duration of 2 seconds. The procedure is repeated three times after a 30-60 second rest period. The maximum pressure value obtained will be recorded.

Unit of Measure: kilopascals (kPa)
Baseline
Maximum Occlusal Force
Time Frame: Baseline

Occlusal force is measured using the Prescale II film. An appropriate size of the film is placed into the mouth, ensuring occlusal surfaces are within the area. The subject is asked to bite down firmly for 3 seconds. The film is then scanned using a dedicated scanner, and specialized software performs image processing to quantify the occlusal force.

Unit of Measure: Newtons (N)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eating Assessment Tool-10 (EAT-10) Score
Time Frame: Baseline

The traditional Chinese version of the EAT-10 is used to assess swallowing dysphagia symptom severity. It consist of 10 questions, each scored from 0 (no problem) to 4 (severe problem). The total score ranges from 0 to 40, with higher scores indicating higher self-perception of swallowing impairment.

Unit of Measure: Score on a scale
Baseline
Daily Meal Frequency
Time Frame: Baseline

Participants report the number of meals consumed on the previous day using a 5-category scale (1, 2, 3, 4, or 5 or more meals).

Unit of Measure: Number of meals per day
Baseline
Dietary Food Texture Consumption
Time Frame: Baseline

Participants identify the texture levels of the foods they currently consume based on the IDDSI (International Dysphagia Diet Standardisation Initiative) framework, ranging from Level 0 to Level 7. Multiple levels may be selected to reflect their dietary range.

Unit of Measure: Percentage of participants reporting each texture level
Baseline
Frequency of Dining Out
Time Frame: Baseline

Participants report their frequency of eating out (including food delivery) on a 5-point ordinal scale (Always, Mostly, Frequently, Occasionally, Never).

Unit of Measure: Percentage of participants per frequency category
Baseline
Self-Reported Pronunciation Difficulty
Time Frame: Baseline

Participants rate their ease of pronunciation using a 4-point ordinal scale: Normal (1), Slightly inconvenient (2), A bit difficult (3), and Very difficult (4).

Unit of Measure: Score on a scale
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 24, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202507230RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Raw Dataset Baseline Characteristics Outcome Measures

IPD Sharing Time Frame

9 months after the end of strudy and last until 24 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dietary Behavior

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Thailand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe