N/A
N=60
The Effect of a Home-based Orofacial Exercise Program on Oral Aperture of Systemic Sclerosis Patients
Microstomia · Systemic Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04336475 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change From Baseline in Oral Aperture Measurement — 32.98; 32.92; 33.40; 34.37 milimeters — p=0.564
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- orofacial exercise program (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Cukurova University
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Oral Aperture Measurement |
32.98; 32.92; 33.40; 34.37 | 0.564 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04336475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.