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 volunteersQualifiers
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
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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)
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)
Secondary outcomes
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
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
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
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
Sponsors and contacts
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