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

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National Taiwan University

Status

Begins enrollment in 1 month

Conditions

Maxillary Defect Reconstruction
Dietary Behavior
Maxillary Obturators

Study type

Observational

Funder types

Other

Identifiers

NCT07390942
202507230RINC

Details and patient eligibility

About

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.

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

40 participants in 1 patient group

Maxillectomy patients with obturator prosthesis

Trial contacts and locations

1

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Central trial contact

Chia-Yuan Hu, MDS

Data sourced from clinicaltrials.gov

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