Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 514
- 试验地点
- 3
- 主要终点
- Self-reported Pain
研究概览
简要总结
Temporomandibular Disorders (TMD) encompass various conditions that affect the temporomandibular joint and associated tissues, often causing or being associated with other symptoms such as jaw pain, myofascial pain, neck pain, and headaches. TMDs are classified according to the DC/TMD instrument in which the joint and pain axes are evaluated. However, there is no evaluation of mandibular function, and TMDs can result in a decrease in jaw strength and resistance. This leads to an increase in the chewing fatigue. Reliable and time-effective diagnostic methods for evaluating masticatory function are crucial in the clinical setting because of the high prevalence of TMD. Chewing efficiency is essential for food preparation and nutrient absorption, and muscle fatigue is a common problem affecting chewing ability. Despite this, there is a lack of validated tests to evaluate chewing fatigue in patients with TMD, which makes its consideration unnoticed in clinical practice.
The modified six-minute functional chewing test (F-6MMT) was proposed as a tool to evaluate chewing ability and fatigue in patients with TMD. This test is an adaptation of a previously designed test in which subjects with mitochondrial pathology were evaluated; however, the subjects were not instructed to perform functional chewing during the test. In this version, modifications are added so that the test is as functional as possible, allowing chewing to be evaluated in a standardized way, and cut-off points established between healthy subjects and subjects with TMD in terms of chewing capacity in general and fatigue in particular. This study will follow standardized reporting guidelines and recruit participants from diverse clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men of legal age
- •With or without TMDs symptoms and
- •With or without self-reported jaw fatigue when eating
排除标准
- •Subjects treated with any type of treatment requiring infiltration of the mandibular region
- •Participants undergoing dental interventions in the last 3 months
- •Individuals missing two or more teeth in the same quadrant.
- •Inability to understand or speak catalan, spanish or english.
结局指标
主要结局
Self-reported Pain
时间窗: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
Score pain on a Numerical Rating Scale (0-10). 0 means no pain and 10 the highest pain possible
Fatigue
时间窗: Immediately before the procedure, immediately after the procedure, and five minutes after the procedure
Score fatigue on a Numerical Rating Scale (0-10). 0 means no fatigue and 10 the highest fatigue possible.
Sensitivity and Specificity
时间窗: through study completion, an average of 1 year
Ability to identificate cases vs controls
Feasibity
时间窗: through study completion, an average of 1 year
Intra and inter examinator feasibility
Replicability
时间窗: Through study completion, an average of 1 year
Consistency and precision of the test
次要结局
- Pain-related TMD diagnosis(Before the procedure)
- Self-reported daily fatigue(Baseline)
- Health status(Before the procedure)
- Pain pressure threshold (PPT)(Immediately before the procedure, immediately after the procedure, and five minutes after the procedure)
- Preferred side when chewing during the F-6MMT(Immediately after the procedure)
- Kinesiofobia related to TMD(Before the procedure)
- Taste of the gum(Immediately after the procedure)
- Comorbidities(Before the procedure)
