Dental Appliance for Parkinson's Disease

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2020-02-10

Brief Summary

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The investigators are evaluating the immediate effect of a dental mouthpiece on gait and balance among people with Parkinson disease as well as longer-term feasibility use and the effect of the mouthpiece on sleep and quality of life.

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Detailed Description

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The investigators are conducting a pilot study with participants who have been diagnosed with Parkinson disease recruited from the community. Participants will attend one in-person visit and be custom fitted with a dental mouthpiece. Participants will be asked to wear the mouthpiece as much as possible for one month including while sleeping and during the day, except while eating.

Participants will be asked to return for a second in-person visit to repeat gait and balance (motor) measures.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dental Mouthpiece

Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans.

Group Type EXPERIMENTAL

Dental Mouthpiece

Intervention Type DEVICE

Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece.

Interventions

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Dental Mouthpiece

Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* have a diagnosis of idiopathic, typical Parkinson Disease according to the United Kingdom Brain Bank Criteria, Hoehn \& Yahr stages 1-3;
* stable Parkinson disease medications for the two weeks prior to baseline visit;
* be able to walk at least 10 meters at baseline with or without an assistive device;
* have their own teeth and/or dentures;
* be willing to try to wear a mouthpiece for one month;
* are over the age of 30; and
* provide written or verbal informed consent.

Exclusion Criteria

* pre-existing medical conditions that would inhibit full participation in the study's tasks;
* absence of any dentition;
* cognitive impairments indicated by Mini Mental Status Exam (MMSE) score of \<24;
* freezing of gait which moderately or severely impacts walking; or
* current use of an oral appliance (e.g., a dental mouthpiece, retainer, or braces).

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No