Trial Outcomes & Findings for The Effect of a Home-based Orofacial Exercise Program on Oral Aperture of Systemic Sclerosis Patients (NCT NCT04336475)
NCT ID: NCT04336475
Last Updated: 2020-04-29
Results Overview
the interincisal distance between the maxillary and mandibular central incisors in the midline
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
2 months
Results posted on
2020-04-29
Participant Flow
Participants were recruited based on randomization in outpatient rheumatology clinic. First patient was enrolled on March 2017 and the last participant was enrolled in October 2018.
156 patients were evaluated and 74 met inclusion criteria. 14 patients refused to participate. 60 patients were randomized.
Participant milestones
| Measure |
Exercise + Oral Hygiene First, Then Oral Hygiene Only
Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care. After the first month, patients continue only with daily oral hygiene care. Exercise regimen includes: 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right \& left molars. 5.The subject pushes the chin to left and right sides.
|
Oral Hygiene Only First, Then Exercise + Oral Hygiene
patients only perform daily oral hygiene care advices for the first month. Patients start performing exercise program in addition to oral hygiene care advices in the second month. Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds. 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right \& left molars. 5.The subject pushes the chin to left and right sides.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Exercise + Oral Hygiene First, Then Oral Hygiene Only
Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care. After the first month, patients continue only with daily oral hygiene care. Exercise regimen includes: 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right \& left molars. 5.The subject pushes the chin to left and right sides.
|
Oral Hygiene Only First, Then Exercise + Oral Hygiene
patients only perform daily oral hygiene care advices for the first month. Patients start performing exercise program in addition to oral hygiene care advices in the second month. Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds. 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right \& left molars. 5.The subject pushes the chin to left and right sides.
|
|---|---|---|
|
Overall Study
pain
|
1
|
0
|
|
Overall Study
upper respiratory infection
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
The Effect of a Home-based Orofacial Exercise Program on Oral Aperture of Systemic Sclerosis Patients
Baseline characteristics by cohort
| Measure |
Exercise + Oral Hygiene First, Then Oral Hygiene Only
n=28 Participants
Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care. After the first month, patients continue only with daily oral hygiene care. Exercise regimen includes: 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right \& left molars. 5.The subject pushes the chin to left and right sides.
|
Oral Hygiene Only First, Then Exercise + Oral Hygiene
n=28 Participants
Patients only perform daily oral hygiene care advices for the first month. Patients start performing exercise program in addition to oral hygiene care advices in the second month. Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds. 1.The subject stretches the lips with fingers. 2. The subject inflates the cheeks. 3.The subject keeps maximal mouth opening. 4. The subject bites a wood stick with right \& left molars. 5.The subject pushes the chin to left and right sides.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
53.82 years
STANDARD_DEVIATION 9.63 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 11.4 • n=7 Participants
|
52 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
oral aperture
|
31.17 milimeters
STANDARD_DEVIATION 4.90 • n=5 Participants
|
33.05 milimeters
STANDARD_DEVIATION 5.53 • n=7 Participants
|
32.11 milimeters
STANDARD_DEVIATION 5.26 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsthe interincisal distance between the maxillary and mandibular central incisors in the midline
Outcome measures
| Measure |
Exercise + Oral Hygiene First, Then Oral Hygiene Only
n=28 Participants
1. st month \> exercise + oral hygiene
2. nd month\> oral hygiene only
|
Oral Hygiene Only First, Then Exercise + Oral Hygiene
n=28 Participants
1. st month\> Oral Hygiene Only
2. nd month \> exercise + oral hygiene
|
|---|---|---|
|
Change From Baseline in Oral Aperture Measurement
1 st month
|
32.98 milimeters
Standard Deviation 5.01
|
32.92 milimeters
Standard Deviation 6.13
|
|
Change From Baseline in Oral Aperture Measurement
2 nd month
|
33.40 milimeters
Standard Deviation 5.33
|
34.37 milimeters
Standard Deviation 6.47
|
Adverse Events
Exercise + Oral Hygiene
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Oral Hygiene Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exercise + Oral Hygiene
n=56 participants at risk
Each exercise should be performed two times per day for 5 repetitions, holding each 10 seconds for one month duration in addition to oral hygiene care.
|
Oral Hygiene Only
n=56 participants at risk
Patients only perform daily oral hygiene care advices
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
pain
|
1.8%
1/56 • Number of events 1 • 2 months
since this is not a drug study mortality and serious adverse events are not expected.
|
0.00%
0/56 • 2 months
since this is not a drug study mortality and serious adverse events are not expected.
|
Additional Information
Dr Nihan Cuzdan, MD, principal investigator
Cukurova University
Phone: 05052706846
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place