Mouth Handicap in Systemic Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS)
Study Overview
Brief Summary
In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.
Detailed Description
Systemic Sclerosis is an autoimmune connective tissue disease with fibrosis. Although its etiology and pathogenesis have not been clearly defined, it has a chronic course. Systemic sclerosis is estimated to affect approximately 300,000 people in the United States. Most commonly, it affects adults and women.
Narrowing of the mouth opening and mouth pain are the two most important causes reported by adults with systemic sclerosis. In patients with systemic sclerosis, orofacial findings such as microstomy or reduced mouth opening are frequently seen. Microstomy is defined as the distance between the incisors is less than 40 millimeters. In severe microstomy, this distance is less than 30 millimeters. It is approximately 33 millimeters in adults with systemic sclerosis. Microstomy in systemic sclerosis mainly results from submucosal collagen deposits that contribute to fibrosis in the perioral tissue. Microstomy is seen in 43% to 80% of adults with systemic sclerosis.
When the current literature is examined, Bongi et al. evaluated the effectiveness of face-specific programs, which are applied together with general rehabilitation programs in patients with systemic sclerosis; they demonstrated that these techniques improve disability, health-related quality of life (HRQoL), and facial functionality.
In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be diagnosed with systemic sclerosis
- •Stability of medical treatments
- •Turkish literacy
Exclusion Criteria
- •The patient has a history of neurological disease or trauma that may affect his symptoms
- •Oral treatment for the last 6 months
- •Being in active phase of the disease
- •Skin infection and presence of open wound
- •Having used dental orthosis in the last month
- •Disorder of cognition or cooperation
Outcomes
Primary Outcomes
Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS)
Time Frame: at first day and second week change
Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS): This is a self-reported scale specific to the disease that questions oral involvement in systemic sclerosis. It consists of 12 items that evaluate features such as mouth opening, chewing, tooth structure, lip structure, dry mouth, fluent speech, and facial appearance. It is answered according to the five-point Likert system: 0: Never, 1: Rarely, 2: Sometimes, 3: Frequently, 4: Always. The higher the total score, the higher the severity of the problem.
Secondary Outcomes
- Eating Assessment Tool (EAT-10)(at first day)
- Scleroderma Health Assessment Questionnaire (SHAQ)(at first day)
- Oral Health Impact Profile (OHIP-14)(at first day)
Investigators
Tugba Civi Karaaslan
Research Assistant
Istanbul University - Cerrahpasa (IUC)