N/A
N=20
Dental Appliance for Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04082663 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Changes in Gait Velocity — 1.10; 1.15 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dental Mouthpiece (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Gait Velocity |
1.10; 1.15 | — |
| PRIMARY Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) |
19.44; 19.28 | — |
| SECONDARY Changes in Parkinson Disease Sleep Scale |
89.32; 91.68 | — |
| SECONDARY Changes in Parkinson Disease Questionnaire-39 |
18.17; 17.34 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04082663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.