Dental Appliance for Parkinson's Disease

Parkinson Disease Clinical Trial

— DAPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082663
• Other study ID #: 201904098
• Status: Completed
• Phase: N/A
• Start date: September 19, 2019
• Est. completion date: February 10, 2020

Study information

• Verified date: February 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 10, 2020
• Est. primary completion date: February 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine Program in Physical Therapy	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

Trenkwalder C, Kohnen R, Högl B, Metta V, Sixel-Döring F, Frauscher B, Hülsmann 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Gait Velocity	Gait velocity will be measured while walking forwards with and without the mouthpiece	Baseline in-person visit
Primary	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.	Baseline in-person visit
Secondary	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).	Baseline and One month
Secondary	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.	Baseline and One month