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NCT Number: NCT06974591

Postural Perturbations Tracing to the Stomatognathic System

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.

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Key information

Conditions

Posture Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Alexandros Tsouknidas, PhD

CONTACT

[email protected]

617-358-8777

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental splints

Other

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.

Dentures

Other

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 outcomes

  1. Center of pressure

    Time frame: 60-90 minutes

    This outcome will be assessed from data collected with a motion capture system (consisting of specialized infrared cameras), which will document the kinematics of reflective markers, placed on the subjects' head and body.

  2. Postural sway

    Time frame: 60-90 minutes

    This outcome will be assessed from data collected with a motion capture system (consisting of specialized infrared cameras), which will document the kinematics of reflective markers, placed on the subjects' head and body.

  3. Stride length

    Time frame: 60-90 minutes

    This outcome will be assessed from data collected with a motion capture system (consisting of specialized infrared cameras), which will document the kinematics of reflective markers, placed on the subjects' head and body.

  4. Step width

    Time frame: 60-90 minutes

    This outcome will be assessed from data collected with a motion capture system (consisting of specialized infrared cameras), which will document the kinematics of reflective markers, placed on the subjects' head and body.

  5. Gait velocity

    Time frame: 60-90 minutes

    This outcome will be assessed from data collected with a motion capture system (consisting of specialized infrared cameras), which will document the kinematics of reflective markers, placed on the subjects' head and body.

  6. Muscle activation

    Time frame: 60-90 minutes

    This outcome will be assessed from data collected with wireless Electromyography (consisting of small sensors), which will document the activation of specific muscle groups, controlling head and jaw position.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandros Tsouknidas, PhD

CONTACT

[email protected]

617-358-8777

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 16, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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