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NCT Number: NCT07390942

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dentistry of National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Yuan Hu, MDS

CONTACT

[email protected]

+886972652202

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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