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Dental Appliance for Parkinson's Disease (DAPD)

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dental Mouthpiece
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Washington University School of Medicine Program in Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dental Mouthpiece

Arm 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.

Outcomes

Primary Outcome Measures

Changes in Gait Velocity
Gait velocity will be measured while walking forwards with and without the mouthpiece
Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
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 Outcome Measures

Changes in Parkinson Disease Sleep Scale
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).
Changes in Parkinson Disease Questionnaire-39
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.

Full Information

First Posted
September 5, 2019
Last Updated
February 8, 2021
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04082663
Brief Title
Dental Appliance for Parkinson's Disease
Acronym
DAPD
Official Title
Evaluating the Effects of a Removable Dental Mouthpiece on Symptoms Associated With Parkinson's
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 19, 2019 (Actual)
Primary Completion Date
February 10, 2020 (Actual)
Study Completion Date
February 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive a custom-fitted dental mouthpiece and asked to wear the mouthpiece for one month.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dental Mouthpiece
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Dental Mouthpiece
Intervention Description
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 Measure Information:
Title
Changes in Gait Velocity
Description
Gait velocity will be measured while walking forwards with and without the mouthpiece
Time Frame
Baseline in-person visit
Title
Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest)
Description
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.
Time Frame
Baseline in-person visit
Secondary Outcome Measure Information:
Title
Changes in Parkinson Disease Sleep Scale
Description
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).
Time Frame
Baseline and One month
Title
Changes in Parkinson Disease Questionnaire-39
Description
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.
Time Frame
Baseline and One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gammon M Earhart, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine Program in Physical Therapy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27977521
Citation
Lane H, Rose LE, Woodbrey M, Arghavani D, Lawrence M, Cavanaugh JT. Exploring the Effects of Using an Oral Appliance to Reduce Movement Dysfunction in an Individual With Parkinson Disease: A Single-Subject Design Study. J Neurol Phys Ther. 2017 Jan;41(1):52-58. doi: 10.1097/NPT.0000000000000160.
Results Reference
background
PubMed Identifier
26044345
Citation
Potter K, Brandfass K. The Mini-Balance Evaluation Systems Test (Mini-BESTest). J Physiother. 2015 Oct;61(4):225. doi: 10.1016/j.jphys.2015.04.002. Epub 2015 Jun 1. No abstract available.
Results Reference
background
PubMed Identifier
9351479
Citation
Jenkinson C, Fitzpatrick R, Peto V, Greenhall R, Hyman N. The Parkinson's Disease Questionnaire (PDQ-39): development and validation of a Parkinson's disease summary index score. Age Ageing. 1997 Sep;26(5):353-7. doi: 10.1093/ageing/26.5.353.
Results Reference
background
PubMed Identifier
21312275
Citation
Trenkwalder C, Kohnen R, Hogl B, Metta V, Sixel-Doring F, Frauscher B, Hulsmann J, Martinez-Martin P, Chaudhuri KR. Parkinson's disease sleep scale--validation of the revised version PDSS-2. Mov Disord. 2011 Mar;26(4):644-52. doi: 10.1002/mds.23476. Epub 2011 Feb 10.
Results Reference
background
PubMed Identifier
23526322
Citation
Moeller DR. Evaluation of a Removable Intraoral Soft Stabilization Splint for the Reduction of Headaches and Nightmares in Military PTSD Patients: A Large Case Series. J Spec Oper Med. 2013 Spring;13(1):49-54.
Results Reference
background

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Dental Appliance for Parkinson's Disease

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