Clinical trial NCT04273386: Mouth Handicap in Systemic Sclerosis
Official title: Mouth Handicap in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Systemic Sclerosis
Mouth Diseases
Keywords: Scleroderma
Systemic sclerosis
Mouth
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2020-02-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS)
timeFrame: at first day and second week change
Secondary outcomes:
measure: Scleroderma Health Assessment Questionnaire (SHAQ)
timeFrame: at first day
measure: Oral Health Impact Profile (OHIP-14)
timeFrame: at first day
measure: Eating Assessment Tool (EAT-10)
timeFrame: at first day
Other outcomes:
Locations:
city: İ̇stanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Research Assistant
name: TUGBA CIVI KARAASLAN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mouthon L, Rannou F, Berezne A, Pagnoux C, Arene JP, Fois 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. doi: 10.1136/ard.2007.070532. Epub 2007 May 14.
citation: 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.
citation: 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.
citation: Scardina GA, Messina P. Systemic sclerosis: description and diagnostic role of the oral phenomena. Gen Dent. 2004 Jan-Feb;52(1):42-7.
citation: 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. doi: 10.1016/0030-4220(84)90309-8.