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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07390942
Enrollment
40
Registered
2026-02-05
Start date
2026-04-01
Completion date
2026-12-31
Last updated
2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Behavior, Maxillary Defect Reconstruction, Maxillary Obturators

Keywords

Obturator, Dental Prescale II, EAT-10, Tongue pressure

Brief summary

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.

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

Interventions

None listed

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum Tongue PressureBaselineTongue 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)
Maximum Occlusal ForceBaselineOcclusal 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

MeasureTime frameDescription
Eating Assessment Tool-10 (EAT-10) ScoreBaselineThe 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
Daily Meal FrequencyBaselineParticipants 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
Dietary Food Texture ConsumptionBaselineParticipants 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
Frequency of Dining OutBaselineParticipants 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
Self-Reported Pronunciation DifficultyBaselineParticipants 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

Countries

Taiwan

Contacts

CONTACTChia-Yuan Hu, MDS
daitsheep@gmail.com+886972652202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026