Mouth Handicap in Systemic Sclerosis
- Conditions
- Systemic SclerosisMouth DiseasesScleroderma
- Interventions
- Other: Evaluation
- Registration Number
- NCT04273386
- Lead Sponsor
- Istanbul University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- To be diagnosed with systemic sclerosis
- Stability of medical treatments
- Turkish literacy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Evaluation Evaluation Cases will be evaluated for oral health and data will be recorded.
- Primary Outcome Measures
Name Time Method Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS) 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 Outcome Measures
Name Time Method Eating Assessment Tool (EAT-10) at first day It is a single factor scale used to evaluate the severity and change of dysphagia symptoms. It consists of ten items. Each item is scored from 0 to 4. The total score ranges from 0 to 40. The scale is considered to be abnormal 3 points or more.
Scleroderma Health Assessment Questionnaire (SHAQ) at first day Scleroderma Health Assessment Questionnaire (SHAQ): The SHAQ includes 5 visual analog scale questions that question Raynaud's phenomenon, digital ulcer, gastrointestinal and pulmonary respiratory symptoms, as well as the patient's overall disease severity. In addition, there are 20 questions (HAQ) evaluating the functional competence level of the patient. Each question is between 0-3 points (0: no difficulty and 3: can not). In the scoring of the sections, the highest score among the items constituting that section is accepted as the section score. The score of each category is summed and divided by the total number of categories, 8 to obtain the SHAQ disability score.
Oral Health Impact Profile (OHIP-14) at first day It is a self-report scale that questions the proportion of individuals experiencing oral health problems. Likert response system; 0: None, 1: Rarely, 2: Sometimes, 3: Often, 4: Very often. The evaluation shows the total score of the participants' responses to each item, while OHIP-14 A (additive) shows the number of responses that a participant gave as 2 (sometimes) and 3 (often) in 14 items. The increase in the total score indicates that the severity of the problem increases and quality of life decreases.
Trial Locations
- Locations (1)
Istanbul University-Cerrahpasa
🇹🇷İ̇stanbul, Turkey