Maxillary ObturatorsNCT07390942
Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
An observational study of Maxillary Obturators and Maxillary Defect Reconstruction, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Maxillary Obturators, Maxillary Defect Reconstruction, Dietary Behavior
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Dentistry of National Taiwan University Hospital
Taipei, 100
About this study
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.
Read the 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
- Keywords
- Obturator, Dental Prescale II, EAT-10, Tongue pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Maxillectomy patients with obturator prosthesis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
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)
Measured: Baseline
Secondary outcomes (5)
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Self-Reported Pronunciation Difficulty
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion24 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Maxillary ObturatorsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390942
- Sponsor's protocol ID
- 202507230RINC
- Status last verified
- Sep 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw Dataset Baseline Characteristics Outcome Measures
Publications
Wang TM, Chang YH, Yang TC, Lin LD. Effect of scan delay on measurements of an occlusal pressure sensitive film: An in-vitro study. J Dent Sci. 2022 Jan;17(1):30-34. doi: 10.1016/j.jds.2021.08.005. Epub 2021 Aug 28.
PubMed 35028017Clark HM, Solomon NP. Age and sex differences in orofacial strength. Dysphagia. 2012 Mar;27(1):2-9. doi: 10.1007/s00455-011-9328-2. Epub 2011 Feb 25.
PubMed 21350818Vanderwegen J, Guns C, Van Nuffelen G, Elen R, De Bodt M. The influence of age, sex, bulb position, visual feedback, and the order of testing on maximum anterior and posterior tongue strength and endurance in healthy belgian adults. Dysphagia. 2013 Jun;28(2):159-66. doi: 10.1007/s00455-012-9425-x. Epub 2012 Sep 16.
PubMed 22983359Zhang PP, Yuan Y, Lu DZ, Li TT, Zhang H, Wang HY, Wang XW. Diagnostic Accuracy of the Eating Assessment Tool-10 (EAT-10) in Screening Dysphagia: A Systematic Review and Meta-Analysis. Dysphagia. 2023 Feb;38(1):145-158. doi: 10.1007/s00455-022-10486-6. Epub 2022 Jul 18.
PubMed 35849209Matsuyama M, Tsukiyama Y, Tomioka M, Koyano K. Clinical assessment of chewing function of obturator prosthesis wearers by objective measurement of masticatory performance and maximum occlusal force. Int J Prosthodont. 2006 May-Jun;19(3):253-7.
PubMed 16752621Shiga H, Komino M, Yokoyama M, Sano M, Arakawa I, Nakajima K, Fujii S. Relationship between age and occlusal force in adults with natural dentition. Odontology. 2023 Apr;111(2):487-492. doi: 10.1007/s10266-022-00750-4. Epub 2022 Sep 28.
PubMed 36169783Miura H, Watanabe S, Isogai E, Miura K. Comparison of maximum bite force and dentate status between healthy and frail elderly persons. J Oral Rehabil. 2001 Jun;28(6):592-5. doi: 10.1046/j.1365-2842.2001.00716.x.
PubMed 11422687Van den Steen L, Vanderveken O, Vanderwegen J, Van Gestel D, Daisne JF, Allouche J, Delacroix L, Van Rompaey D, Beauvois S, Cvilic S, Marien S, Desuter G, Vermorken JB, Van den Weyngaert D, Specenier P, Van Laer C, Peeters M, Van de Heyning P, Chantrain G, Lawson G, Lazarus C, De Bodt M, Van Nuffelen G; Member of the Belgian Cancer Plan 29_033_Dysphagia Group. Feasibility of tongue strength measurements during (chemo)radiotherapy in head and neck cancer patients. Support Care Cancer. 2017 Nov;25(11):3417-3423. doi: 10.1007/s00520-017-3761-1. Epub 2017 Jun 2.
PubMed 28573486Lazarus CL, Logemann JA, Pauloski BR, Rademaker AW, Larson CR, Mittal BB, Pierce M. Swallowing and tongue function following treatment for oral and oropharyngeal cancer. J Speech Lang Hear Res. 2000 Aug;43(4):1011-23. doi: 10.1044/jslhr.4304.1011.
PubMed 11386468Tanaka A, Uemura H, Kimura T, Nishimura A, Aoki K, Otsuka S, Ueda K, Kitahara T. Evaluation of usefulness of tongue pressure measurement device for dysphagia associated with treatment of patients with head and neck cancer (ELEVATE). Medicine (Baltimore). 2023 Jun 30;102(26):e33954. doi: 10.1097/MD.0000000000033954.
PubMed 37390259Adams V, Mathisen B, Baines S, Lazarus C, Callister R. Reliability of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument with healthy adults. Dysphagia. 2014 Feb;29(1):83-95. doi: 10.1007/s00455-013-9486-5. Epub 2013 Sep 18.
PubMed 24045852Brown JS, Shaw RJ. Reconstruction of the maxilla and midface: introducing a new classification. Lancet Oncol. 2010 Oct;11(10):1001-8. doi: 10.1016/S1470-2045(10)70113-3.
PubMed 20932492
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
- ClinicalTrials.gov ID
- NCT07390942
- Acronym / sponsor ID
- 202507230RINC
- Keywords
- Obturator, Dental Prescale II, EAT-10, Tongue pressure
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 24 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maxillectomy patients with obturator prosthesis | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
5 secondary outcomes
Eating Assessment Tool-10 (EAT-10) Score
Time frame: Baseline
Daily Meal Frequency
Time frame: Baseline
Dietary Food Texture Consumption
Time frame: Baseline
Frequency of Dining Out
Time frame: Baseline
Self-Reported Pronunciation Difficulty
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Results publication: PubMed 35028017Wang TM, Chang YH, Yang TC, Lin LD. Effect of scan delay on measurements of an occlusal pressure sensitive film: An in-vitro study. J Dent Sci. 2022 Jan;17(1):30-34. doi: 10.1016/j.jds.2021.08.005. Epub 2021 Aug 28.
- Results publication: PubMed 21350818Clark HM, Solomon NP. Age and sex differences in orofacial strength. Dysphagia. 2012 Mar;27(1):2-9. doi: 10.1007/s00455-011-9328-2. Epub 2011 Feb 25.
- Results publication: PubMed 22983359Vanderwegen J, Guns C, Van Nuffelen G, Elen R, De Bodt M. The influence of age, sex, bulb position, visual feedback, and the order of testing on maximum anterior and posterior tongue strength and endurance in healthy belgian adults. Dysphagia. 2013 Jun;28(2):159-66. doi: 10.1007/s00455-012-9425-x. Epub 2012 Sep 16.
- Results publication: PubMed 35849209Zhang PP, Yuan Y, Lu DZ, Li TT, Zhang H, Wang HY, Wang XW. Diagnostic Accuracy of the Eating Assessment Tool-10 (EAT-10) in Screening Dysphagia: A Systematic Review and Meta-Analysis. Dysphagia. 2023 Feb;38(1):145-158. doi: 10.1007/s00455-022-10486-6. Epub 2022 Jul 18.
- Results publication: PubMed 16752621Matsuyama M, Tsukiyama Y, Tomioka M, Koyano K. Clinical assessment of chewing function of obturator prosthesis wearers by objective measurement of masticatory performance and maximum occlusal force. Int J Prosthodont. 2006 May-Jun;19(3):253-7.
- Results publication: PubMed 36169783Shiga H, Komino M, Yokoyama M, Sano M, Arakawa I, Nakajima K, Fujii S. Relationship between age and occlusal force in adults with natural dentition. Odontology. 2023 Apr;111(2):487-492. doi: 10.1007/s10266-022-00750-4. Epub 2022 Sep 28.
- Results publication: PubMed 11422687Miura H, Watanabe S, Isogai E, Miura K. Comparison of maximum bite force and dentate status between healthy and frail elderly persons. J Oral Rehabil. 2001 Jun;28(6):592-5. doi: 10.1046/j.1365-2842.2001.00716.x.
- Results publication: PubMed 28573486Van den Steen L, Vanderveken O, Vanderwegen J, Van Gestel D, Daisne JF, Allouche J, Delacroix L, Van Rompaey D, Beauvois S, Cvilic S, Marien S, Desuter G, Vermorken JB, Van den Weyngaert D, Specenier P, Van Laer C, Peeters M, Van de Heyning P, Chantrain G, Lawson G, Lazarus C, De Bodt M, Van Nuffelen G; Member of the Belgian Cancer Plan 29_033_Dysphagia Group. Feasibility of tongue strength measurements during (chemo)radiotherapy in head and neck cancer patients. Support Care Cancer. 2017 Nov;25(11):3417-3423. doi: 10.1007/s00520-017-3761-1. Epub 2017 Jun 2.
- Results publication: PubMed 11386468Lazarus CL, Logemann JA, Pauloski BR, Rademaker AW, Larson CR, Mittal BB, Pierce M. Swallowing and tongue function following treatment for oral and oropharyngeal cancer. J Speech Lang Hear Res. 2000 Aug;43(4):1011-23. doi: 10.1044/jslhr.4304.1011.
- Results publication: PubMed 37390259Tanaka A, Uemura H, Kimura T, Nishimura A, Aoki K, Otsuka S, Ueda K, Kitahara T. Evaluation of usefulness of tongue pressure measurement device for dysphagia associated with treatment of patients with head and neck cancer (ELEVATE). Medicine (Baltimore). 2023 Jun 30;102(26):e33954. doi: 10.1097/MD.0000000000033954.
- Results publication: PubMed 24045852Adams V, Mathisen B, Baines S, Lazarus C, Callister R. Reliability of measurements of tongue and hand strength and endurance using the Iowa Oral Performance Instrument with healthy adults. Dysphagia. 2014 Feb;29(1):83-95. doi: 10.1007/s00455-013-9486-5. Epub 2013 Sep 18.
- Results publication: PubMed 20932492Brown JS, Shaw RJ. Reconstruction of the maxilla and midface: introducing a new classification. Lancet Oncol. 2010 Oct;11(10):1001-8. doi: 10.1016/S1470-2045(10)70113-3.
- Individual participant dataSharing planned: Yes. Raw Dataset Baseline Characteristics Outcome Measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maxillary Obturators and Maxillary Defect Reconstruction, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Yuan Hu, MDS (+886972652202, daitsheep@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tongue Pressure (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07390942, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.