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

NCT07390942 | Not Yet Recruiting

• 1 other identifier: 202507230RINC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maxillary Obturators; Dietary Behavior; Maxillary Defect Reconstruction

Keywords

Obturator; Dental Prescale II; EAT-10; Tongue pressure

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Baseline

Secondary Outcomes (5)

• Eating Assessment Tool-10 (EAT-10) Score

  Baseline

• Daily Meal Frequency

  Baseline

• Dietary Food Texture Consumption

  Baseline

• Frequency of Dining Out

  Baseline

• Self-Reported Pronunciation Difficulty

  Baseline

Study Arms (1)

Maxillectomy patients with obturator prosthesis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Dentistry of National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (12)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Zhang PP, Yuan Y, Lu DZ, et al. Diagnostic Accuracy of the Eating Assessment Tool-10 (EAT-10) in Screening Dysphagia: A Systematic Review and Meta-Analysis. Dysphagia. 2023;38(1):145-158.

  RESULT

• 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 RESULT

• Shiga H, Komino M, Yokoyama M, et al. Relationship between age and occlusal force in adults with natural dentition. Odontology. 2023;111(2):487-492.

  RESULT

• 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;28(6):592-595.

  RESULT

• Van den Steen L, Vanderveken O, Vanderwegen J, et al. 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 Canc 2017;25:3417-23.

  RESULT

• Lazarus CL, Logemann JA, Pauloski BR, et al. Swallowing and tongue function following treatment for oral and oropharygeal cancer. J Speech Lang Hear Res 2000;43:1011-23.

  RESULT

• Tanaka A, Uemura H, Kimura T, et al. Evaluation of usefulness of tongue pressure measurement device for dysphagia associated with treatment of patients with head and neck cancer (ELEVATE). Medicine (Baltimore). 2023;102(26):e33954.

  RESULT

• Adams 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.

  PMID: 24045852 RESULT

• Brown 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.

  PMID: 20932492 RESULT

Central Study Contacts

Chia-Yuan Hu, MDS

CONTACT

+886972652202; daitsheep@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: February 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 9 months after the end of strudy and last until 24 months

Locations

TW (1)