Postural Perturbations Tracing to the Stomatognathic System

Обзор

A connection of the stomatognathic system \[an anatomical system comprising the teeth, jaws, and associated soft tissues\] to postural control has been suggested in the literature. This research will investigate how occlusion can impact postural response, disorder, and rehabilitation by examining how modifications in the vertical dimension of occlusion (VDO) influence balance and gait. Although it is currently unclear which or how restorative approaches cause postural disturbances, changes in several occlusal factors, i.e. VDO, Angle's class, crossbite and others have been suggested to manifest clearly into an altered stability, which could have a significant effect on the quality of life, especially in the elderly. The present study aims to identify the degree to which specific interventions in oral cavity affect the stability and gait patterns of patients, This will b achieved by either: * The use of dental splints (fully certified devices) * The use of the subjects' own dentures A direct correlation of postural perturbations and VDO, would essentially void the necessity to evaluate specific interventions (e.g. different types of restorations) independently and allow clinicians to assess a potential effect on their patients' stability and gait based on pre- to post- treatment VDO.

Вмешательства

• Другое Dental splints
  Each participant will receive six custom-made dental splints to incrementally increase their VDO. These splints will alter the VDO in increments from 5 to 30 mm, specifically: 5, 10, 15, 20, 25, and 30 mm.
• Другое Dentures
  Participants in this group will participate in balance and gait testing both with and without their dentures to examine how the presence or absence of dentures affects postural stability and movement.

Первичные конечные точки

• Center of pressure [Срок оценки: 60-90 minutes]
• Postural sway [Срок оценки: 60-90 minutes]
• Stride length [Срок оценки: 60-90 minutes]
• Step width [Срок оценки: 60-90 minutes]
• Gait velocity [Срок оценки: 60-90 minutes]
• Muscle activation [Срок оценки: 60-90 minutes]

Критерии участия

Inclusion Criteria for Group A

• 30-45 years old
• Physically and cognitively healthy (able to easily walk without assistance)
• Possessing a complete set of teeth (either natural or restored with crowns)
• Classified as Class I malocclusion according to Angle's criteria.

Inclusion criteria for Group B

• 50-65 years old
• Physically and cognitively healthy (able to easily walk without assistance)
• Fully edentulous
• Wear complete dentures

Критерии исключения

• Parkinson's Disease
• Morbid obesity i.e. BMI values exceeding 40, calculated based on body weight and height requested over the phone or during the visit
• Occlusion altered due to a non-physiological condition i.e. trauma or pathology
• Active temporomandibular joint disorder
• Pregnancy, as pregnancy-related physiological changes could influence the study's balance and gait measurements. This exclusion will be based on self-report during the screening process, and no additional testing will be conducted.
• Any other condition that in the opinion of the study researchers has potential to impact balance or gait

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Goldman School of Dental Medicine, Boston University — Boston

Идентификаторы

NCT: NCT06974591 · H-45251

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗