Department of Dentistry of National Taiwan University Hospital
Taipei, 100, Taiwan
NCT Number: NCT07390942
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Observational
Taipei, 100, Taiwan
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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)
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
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