What this study is
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.
What's being tested
- Dental splints
Intervention · 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
Intervention · 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.
Study details
- Sponsor
- Boston University
- Conditions
- Posture
- Enrolling
- 40 people
- Starts
- 2025-11-17
- Est. completion
- 2027-06
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 30 Years – 65 YearsSex ALLHealthy volunteers Not acceptedGroup A
You may qualify if
- 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.
You can't join 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
- 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
Group B
You may qualify if
- 50-65 years old
- Physically and cognitively healthy (able to easily walk without assistance)
- Fully edentulous
- Wear complete dentures
You can't join 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
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openGoldman School of Dental Medicine, Boston University
Boston, Massachusetts, United States
- Alexandros Tsouknidas, PhD · Contact617-358-8777atsouk@bu.edu
Recruiting
Study team
Sponsor
Boston University
Study ID H-45251
Principal investigator
Alexandros Tsouknidas, PhD
Goldman School of Dental Medicine, Boston University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.