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临床试验/NCT06298786
NCT06298786尚未招募不适用

Validation and Evaluation of the Mastication Function in Adults: The Functional Six-minute Mastication Test (F-6MMT).

Fundació Universitària del Bages3 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2025年9月最近更新:
适应症

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)

研究者

发起方
Fundació Universitària del Bages
申办方类型
Other
责任方
Sponsor

研究点 (3)

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