Skip to main content
OpenTrials
Completed

NCT Number: NCT04082663

Dental Appliance for Parkinson's Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine Program in Physical Therapy

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Dental Mouthpiece

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.

Primary outcomes

  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-Balance Evaluation Systems Test (Mini-BESTest) with and without the mouthpiece. The assessment includes 14 items each of which is rated on a three-point scale (2: Normal, 1: Moderate, 0: Severe). The 14 item scores are summed for a total score. The range of scores is 0 to 28, and higher scores indicate better balance function.

Secondary outcomes

  1. Changes in Parkinson Disease Sleep Scale

    Time frame: Baseline and 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: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's

Acronym: DAPD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 9, 2019
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.