Postural Perturbations Tracing to the Stomatognathic System

NCT ID: NCT06974591

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-17
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group A- dental splints

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.

Group Type: ACTIVE_COMPARATOR

Dental splints

Intervention Type: 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 B- dentures

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

Group Type: ACTIVE_COMPARATOR

Dentures

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandros Tsouknidas, PhD

Role: PRINCIPAL_INVESTIGATOR

Goldman School of Dental Medicine, Boston University

Locations

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandros Tsouknidas, PhD

Role: CONTACT

atsouk@bu.edu

617-358-8777

Facility Contacts

Alexandros Tsouknidas, PhD

Role: primary

atsouk@bu.edu

617-358-8777

Other Identifiers

H-45251

Identifier Type: -

Identifier Source: org_study_id