Mouth Handicap in Systemic Sclerosis


In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2, 2022

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.


  • Other: Evaluation
    • The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.

Arms, Groups and Cohorts

  • Experimental: Evaluation
    • Cases will be evaluated for oral health and data will be recorded.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Scleroderma Health Assessment Questionnaire (SHAQ)
    • Time Frame: 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)
    • Time Frame: 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.
  • Eating Assessment Tool (EAT-10)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Istanbul University
  • Collaborator
    • Istanbul University-Cerrahpasa
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tugba Civi Karaaslan, Research Assistant – Istanbul University-Cerrahpasa
  • Overall Official(s)
    • TUGBA CIVI KARAASLAN, MSc, Principal Investigator, Research Assistant
  • Overall Contact(s)
    • TUGBA CIVI KARAASLAN, MSc, +905343855606,


Mouthon L, Rannou F, Bérezné A, Pagnoux C, Arène JP, Foïs E, Cabane J, Guillevin L, Revel M, Fermanian J, Poiraudeau S. Development and validation of a scale for mouth handicap in systemic sclerosis: the Mouth Handicap in Systemic Sclerosis scale. Ann Rheum Dis. 2007 Dec;66(12):1651-5. Epub 2007 May 14.

Maddali Bongi S, Del Rosso A, Miniati I, Galluccio F, Landi G, Tai G, Matucci-Cerinic M. The Italian version of the Mouth Handicap in Systemic Sclerosis scale (MHISS) is valid, reliable and useful in assessing oral health-related quality of life (OHRQoL) in systemic sclerosis (SSc) patients. Rheumatol Int. 2012 Sep;32(9):2785-90. doi: 10.1007/s00296-011-2049-x. Epub 2011 Aug 17.

Schouffoer AA, Strijbos E, Schuerwegh AJ, Mouthon L, Vliet Vlieland TP. Translation, cross-cultural adaptation, and validation of the Mouth Handicap in Systemic Sclerosis questionnaire (MHISS) into the Dutch language. Clin Rheumatol. 2013 Nov;32(11):1649-55. doi: 10.1007/s10067-013-2321-4. Epub 2013 Jul 24.

Scardina GA, Messina P. Systemic sclerosis: description and diagnostic role of the oral phenomena. Gen Dent. 2004 Jan-Feb;52(1):42-7.

Naylor WP, Douglass CW, Mix E. The nonsurgical treatment of microstomia in scleroderma: a pilot study. Oral Surg Oral Med Oral Pathol. 1984 May;57(5):508-11.

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