Postural Perturbations Tracing to the Stomatognathic System

NCT06974591 | Recruiting

• 1 other identifier: H-45251
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Posture

Keywords

Dental splints; Dentures; Vertical Dimension of Occlusion; Temporomandibular Joint Disorders; Balance; Gait

Outcome Measures

Primary Outcomes (6)

• Center of pressure

  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.

  60-90 minutes

• Postural sway

  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.

  60-90 minutes

• Stride length

  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.

  60-90 minutes

• Step width

  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.

  60-90 minutes

• Gait velocity

  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.

  60-90 minutes

• Muscle activation

  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.

  60-90 minutes

Study Arms (2)

Group A- dental splints

ACTIVE COMPARATOR

Participants in this group will be adults aged 30-45 with complete dentition and Class I malocclusion. Participants must have a complete set of teeth, either natural or with crowns, ensuring no teeth are missing.

Other: Dental splints

Group B- dentures

ACTIVE COMPARATOR

Participants in this group will be older adults aged 50-65 who are edentulous (without natural teeth) and wear full dentures.

Other: Dentures

Interventions

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.

Group A- dental splints

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.

Group B- dentures

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Any other condition that in the opinion of the study researchers has potential to impact balance or gait

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Occlusal Splints; Dentures

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants

Study Officials

• Alexandros Tsouknidas, PhD

  Goldman School of Dental Medicine, Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandros Tsouknidas, PhD

CONTACT

617-358-8777; atsouk@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: November 17, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)