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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Maxillectomy patients with obturator prosthesis

Trial outcomes

Primary outcomes

1

Maximum Tongue Pressure

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)

Time frame
Baseline
2

Maximum Occlusal Force

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)

Time frame
Baseline

Secondary outcomes

1

Eating Assessment Tool-10 (EAT-10) Score

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

Time frame
Baseline
2

Daily Meal Frequency

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

Time frame
Baseline
3

Dietary Food Texture Consumption

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

Time frame
Baseline
4

Frequency of Dining Out

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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