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Dental Appliance for Parkinson's Disease (DAPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082663
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Gammon M Earhart, Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Dental Mouthpiece Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's
Actual Study Start Date : September 19, 2019
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : February 29, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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.




Primary Outcome Measures :
  1. Changes in Gait Velocity [ Time Frame: Baseline in-person visit ]
    Gait velocity will be measured while walking forwards with and without the mouthpiece

  2. Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) [ Time Frame: Baseline in-person visit ]
    Balance will be measured with the Mini-BESTest with and without the mouthpiece


Secondary Outcome Measures :
  1. Changes in Parkinson Disease Sleep Scale [ Time Frame: One month ]
    Indicators of sleep quality will be measured before and after wearing mouthpiece for one-month. The visual analog scale has 15 commonly reported symptoms associated with sleep disturbance (e.g., overall quality of nights sleep, restlessness, daytime dozing). Participants mark a cross along a 10 cm line labelled worst to best state. Items are scored by measuring the distance along each line to the intersection with the cross in centimeters. Each item score can range from 0 - symptom severe and always experienced to 10 - symptom-free. The items are summed and the maximum cumulative score is 150 (free of all symptoms).

  2. Changes in Parkinson Disease Questionnaire-39 [ Time Frame: One month ]
    Quality of life will be measured before and after wearing mouthpiece for one-month. This scale has 39 questions with 5 possible answers (0 = never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always). There are eight dimensions: Mobility questions (q)1-10; Activities of Daily Living q11-16; Emotional well-being q17-22; Stigma q23-26; Social Support q27-29; Cognitive impairment q30-33; Communication q34-36; and Bodily Discomfort q37-39. Dimensions are calculated on a scale of 0 to 100, 0 is no problem at all and 100 is maximum level of a problem. The formula for scoring each dimension: (sum of scores of each question in dimension/4 (max.score per question) x nos. questions in dimension)x100. The formula for a total score (called single index) is sum of dimension scores/8.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082663


Locations
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United States, Missouri
Washington University School of Medicine Program in Physical Therapy
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Publications:
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Responsible Party: Gammon M Earhart, Director, Program in Physical Therapy, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04082663    
Other Study ID Numbers: 201904098
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases