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Postural Perturbations Tracing to the Stomatognathic System

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 30 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06974591
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Boston University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alexandros Tsouknidas, PhD
Principal Investigator Affiliation Goldman School of Dental Medicine, Boston University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Posture
Arms & Interventions

Arms

Active Comparator: 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.

Active Comparator: Group B- dentures

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

Interventions

Other: - 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.

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Address

Goldman School of Dental Medicine, Boston University

Boston, Massachusetts, 02118

Site Contact

Alexandros Tsouknidas, PhD

[email protected]

617-358-8777

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