Mouth Handicap in Systemic Sclerosis

Istanbul University

Status: Completed

Conditions: Mouth Diseases; Scleroderma; Systemic Sclerosis

Treatments: Other: Evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT04273386

ISTANBULC1

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Evaluation

Experimental group

Description:

Cases will be evaluated for oral health and data will be recorded.

Treatment:

Other: Evaluation