Postural Perturbations Tracing to the Stomatognathic System

Overview

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.

Interventions

• Other 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.
• Other 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.

Primary outcome measures

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

Eligibility criteria

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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• Goldman School of Dental Medicine, Boston University — Boston

Identifiers

NCT: NCT06974591 · H-45251

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗