Trial Outcomes & Findings for Dental Appliance for Parkinson's Disease (NCT NCT04082663)

NCT ID: NCT04082663

Last Updated: 2021-02-24

Results Overview

Gait velocity will be measured while walking forwards with and without the mouthpiece

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline in-person visit

Results posted on

2021-02-24

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	20
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.
Overall Study Adverse Event	6
Overall Study Lost to Follow-up	1

Baseline Characteristics

Dental Appliance for Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dental Mouthpiece n=20 Participants Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. 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.
Age, Continuous	66.9 years STANDARD_DEVIATION 9.75 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	20 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	20 participants n=93 Participants
Movement Disorders Society - United Parkinson Disease Rating Scale III	37.25 scores on a scale STANDARD_DEVIATION 8.67 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline in-person visit

Gait velocity will be measured while walking forwards with and without the mouthpiece

Outcome measures

Outcome measures
Measure	Dental Mouthpiece n=20 Participants Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. 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.
Changes in Gait Velocity WITHOUT-Mouthpiece	1.10 m/s Standard Deviation 0.24
Changes in Gait Velocity WITH-Mouthpiece	1.15 m/s Standard Deviation 0.22

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dental Mouthpiece n=20 Participants Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. 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.
Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) WITHOUT-Mouthpiece	19.44 score on a scale Standard Deviation 3.58
Changes in Mini-Balance Evaluation Systems Test (Mini-BESTest) WITH-Mouthpiece	19.28 score on a scale Standard Deviation 4.06

SECONDARY outcome

Timeframe: Baseline and One month

Population: 2 participants missing data

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).

Outcome measures

Outcome measures
Measure	Dental Mouthpiece n=11 Participants Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. 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.
Changes in Parkinson Disease Sleep Scale WITHOUT-Mouthpiece at Baseline	89.32 score on a scale Standard Deviation 29.45
Changes in Parkinson Disease Sleep Scale One-Month Follow-Up	91.68 score on a scale Standard Deviation 29.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dental Mouthpiece n=13 Participants Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. 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.
Changes in Parkinson Disease Questionnaire-39 WITHOUT-Mouthpiece at Baseline	18.17 score on a scale Standard Deviation 9.22
Changes in Parkinson Disease Questionnaire-39 One-Month Follow-Up	17.34 score on a scale Standard Deviation 11.09

Adverse Events

Dental Mouthpiece

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dental Mouthpiece n=20 participants at risk Each participant will be fitted with a maxillary orthotic (mouthpiece). The mouthpiece is fabricated with polyvinyl ethylene acetate which is non-toxic to humans. 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.
Product Issues Irritation/Discomfort from mouthpiece	35.0% 7/20 • Number of events 9 • One month
Surgical and medical procedures Loose filling replaced	5.0% 1/20 • Number of events 1 • One month

Additional Information

Dr. Gammon Earhart

Washington University School of Medicine

Phone: 314-286-1407

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place