Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Maxillary Obturators, Maxillary Defect Reconstruction, Dietary Behavior. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Maximum Tongue Pressure [Time frame: Baseline]
- Maximum Occlusal Force [Time frame: Baseline]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Taiwan · 1 center
- Department of Dentistry of National Taiwan University Hospital — Taipei
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. PMID 35028017
- Clark 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. PMID 21350818
- Vanderwegen 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. PMID 22983359
- Zhang 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. PMID 35849209
- Matsuyama 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. PMID 16752621
- Shiga 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. PMID 36169783
- Miura 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. PMID 11422687
- Van 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 measur PMID 28573486
Identifiers
NCT: NCT07390942 · 202507230RINC