Postural Perturbations Tracing to the Stomatognathic System

Boston University

Status: Begins enrollment this month

Conditions: Posture

Treatments: Other: Dentures; Other: Dental splints

Study type: Interventional

Funder types: Other

Identifiers

NCT06974591

H-45251

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group A- dental splints

Active Comparator group

Description:

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.

Treatment:

Other: Dental splints

Group B- dentures

Active Comparator group

Description:

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

Treatment:

Other: Dentures