Dental Appliance for Parkinson's Disease (DAPD)

The Washington University

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Dental Mouthpiece

Study type: Interventional

Funder types: Other

Identifiers

NCT04082663

201904098

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Dental Mouthpiece

Experimental group

Description:

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

Treatment:

Device: Dental Mouthpiece