PostureNCT06974591
Postural Perturbations Tracing to the Stomatognathic System
A study testing Dental splints and Dentures in people with Posture, run by Boston University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Posture
- What is being tested?
- Dental splints and Dentures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Goldman School of Dental Medicine, Boston University
Boston, Massachusetts, 02118
Alexandros Tsouknidas, PhD, 617-358-8777, atsouk@bu.edu
About this study
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.
Read more
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
- Being tested
- Dental splints, Dentures
- Keywords
- Dental splints, Dentures, Vertical Dimension of Occlusion, Temporomandibular Joint Disorders, Balance, Gait
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental splintsOther
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.
DenturesOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dentures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60-90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start17 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandros Tsouknidas, PhD, Principal investigator, Goldman School of Dental Medicine, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974591
- Sponsor's protocol ID
- H-45251
- Status last verified
- Dec 2025
- First submitted
- 8 May 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Perturbations Tracing to the Stomatognathic System
- ClinicalTrials.gov ID
- NCT06974591
- Acronym / sponsor ID
- H-45251
- Conditions
- Posture
- Keywords
- Dental splints, Dentures, Vertical Dimension of Occlusion, Temporomandibular Joint Disorders, Balance, Gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A- dental splints | Active comparator | Other: Dental splintsParticipants 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 B- dentures | Active comparator | Other: DenturesParticipants in this group will be older adults aged 50-65 who are edentulous (without natural teeth) and wear full dentures. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental splintsEach 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. | Other | Group A- dental splints |
| DenturesParticipants 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. | Other | Group B- dentures |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandros Tsouknidas, PhD principal investigator
Goldman School of Dental Medicine, Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental splints and Dentures in people with Posture, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandros Tsouknidas, PhD (617-358-8777, atsouk@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center of pressure (time frame: 60-90 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025; AzTrials last refreshed its copy on 30 Oct 2026.