Tongue and Occlusal Pressure Performance and Dietary Habits in Maxillectomy Patients With Obturator Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Maximum Tongue Pressure
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Ability to provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
Maxillectomy patients with obturator prosthesis
结局指标
主要结局
Maximum Tongue Pressure
时间窗: 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
时间窗: 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)
次要结局
- 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)