Microstomia, Systemic Sclerosis
Conditions
Keywords
exercise, microstomia, oral aperture, rehabilitation, systemic sclerosis
Brief summary
Systemic sclerosis is a systemic disease which may involve multiple organ systems and cause functional disabilities. Microstomia is one of the most common complications of the disease which may result in difficulties performing oral self-care, complication in professional dental care and even malnutrition in the advanced cases. Since the disease is rare and the studies are limited, there is still not an agreed upon orofacial exercise program to improve the oral aperture of the patients. Therefore, we aimed to investigate the effect of a newly diseased home-based exercise program for improving microstomia in those patient population.
Detailed description
The study was designed as a single-blind, prospective, randomized controlled study with a 2-month follow-up period, carried out in rheumatology outpatient clinic, between March 2017 - January 2019. Systemic sclerosis patients with an oral aperture of \<40mm were included in the study. Patients were randomly divided into two groups. Randomization was done as the sealed envelope method. After the informed consent was taken, the opaque envelope that the patient have chosen was opened and patients were offered the allocated treatment regimen. Group 1 was given exercise regimen and oral hygiene care advices for the first one month; followed by no exercise but oral hygiene care advices for the next four weeks. Group 2, as the control group, received oral hygiene care advices for the first one month, followed by the exercise regimen twice a day along with oral hygiene care advices for the next four weeks. Oral care advices were given to every participant by a dentist involved in the study at their first visit. With this protocol, we aimed (a) to investigate whether there is a benefit of the exercise program on microstomia; (b) to observe the carryover effect of exercise therapy on microstomia after discontinuing the treatment over a period of time; (c) to estimate the intervention strategy by comparing the same medical approach with different sequences. The exercise program was demonstrated to patients by a clinician at the first visit and given to all patients printed as a manual to be done every day for one month duration of the exercise program. Additionally, a diary was given to patients to mark when they have completed the exercise and to note in the case of pain on daily basis. The exercise regimen was developed on the basis of previous studies and clinical knowledge.
Interventions
OTHERorofacial exercise program
combined stretching&strengthening exercise regimen
Sponsors
Cukurova University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\* systemic sclerosis patients with an interincisal distance of \<40 mm
Exclusion criteria
* patients with missing teeth * dysfunction of temporo-mandibular joints * oral malignancy * recent dental procedures * multiple active digital ulcers * diagnosed psychiatric conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Oral Aperture Measurement | 2 months | the interincisal distance between the maxillary and mandibular central incisors in the midline |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
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.
Pre-assignment details
156 patients were evaluated and 74 met inclusion criteria. 14 patients refused to participate. 60 patients were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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. | 28 |
| Total | 56 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | pain | 1 | 0 |
| Overall Study | upper respiratory infection | 1 | 0 |
Baseline characteristics
| Characteristic | Exercise + Oral Hygiene First, Then Oral Hygiene Only | Oral Hygiene Only First, Then Exercise + Oral Hygiene | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 24 Participants | 46 Participants |
| Age, Continuous | 53.82 years STANDARD_DEVIATION 9.63 | 50.0 years STANDARD_DEVIATION 11.4 | 52 years STANDARD_DEVIATION 11 |
| oral aperture | 31.17 milimeters STANDARD_DEVIATION 4.9 | 33.05 milimeters STANDARD_DEVIATION 5.53 | 32.11 milimeters STANDARD_DEVIATION 5.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 28 Participants | 56 Participants |
| Region of Enrollment Turkey | 28 participants | 28 participants | 56 participants |
| Sex: Female, Male Female | 27 Participants | 26 Participants | 53 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 1 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
Change From Baseline in Oral Aperture Measurement
the interincisal distance between the maxillary and mandibular central incisors in the midline
Time frame: 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise + Oral Hygiene First, Then Oral Hygiene Only | Change From Baseline in Oral Aperture Measurement | 1 st month | 32.98 milimeters | Standard Deviation 5.01 |
| Exercise + Oral Hygiene First, Then Oral Hygiene Only | Change From Baseline in Oral Aperture Measurement | 2 nd month | 33.40 milimeters | Standard Deviation 5.33 |
| Oral Hygiene Only First, Then Exercise + Oral Hygiene | Change From Baseline in Oral Aperture Measurement | 1 st month | 32.92 milimeters | Standard Deviation 6.13 |
| Oral Hygiene Only First, Then Exercise + Oral Hygiene | Change From Baseline in Oral Aperture Measurement | 2 nd month | 34.37 milimeters | Standard Deviation 6.47 |
p-value: 0.564ANOVA