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Completed

NCT Number: NCT04273386

Mouth Handicap in Systemic Sclerosis

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

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Key information

Conditions

Scleroderma Connective Tissue Diseases Mouth Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Systemic Sclerosis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation

Other

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Istanbul University - Cerrahpasa

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2020
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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