Clinical trial NCT06974591: Postural Perturbations Tracing to the Stomatognathic System
Official title: Postural Perturbations Tracing to the Stomatognathic System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Posture
Keywords: Dental splints
Dentures
Vertical Dimension of Occlusion
Temporomandibular Joint Disorders
Balance
Gait
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


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

Primary outcomes:
measure: Center of pressure
timeFrame: 60-90 minutes
measure: Postural sway
timeFrame: 60-90 minutes
measure: Stride length
timeFrame: 60-90 minutes
measure: Step width
timeFrame: 60-90 minutes
measure: Gait velocity
timeFrame: 60-90 minutes
measure: Muscle activation
timeFrame: 60-90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Goldman School of Dental Medicine, Boston University
state: Massachusetts
Study officials:
affiliation: Goldman School of Dental Medicine, Boston University
name: Alexandros Tsouknidas, PhD
role: PRINCIPAL_INVESTIGATOR
References: