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Mouth Handicap in Systemic Sclerosis

Primary Purpose

Scleroderma, Systemic Sclerosis, Mouth Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Evaluation
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Scleroderma focused on measuring Scleroderma, Systemic sclerosis, Mouth

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istanbul University-Cerrahpasa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluation

Arm Description

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

Outcomes

Primary Outcome Measures

Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS)
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

Scleroderma Health Assessment Questionnaire (SHAQ)
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)
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)
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.

Full Information

First Posted
November 26, 2019
Last Updated
April 12, 2022
Sponsor
Istanbul University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04273386
Brief Title
Mouth Handicap in Systemic Sclerosis
Official Title
Mouth Handicap in Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
Collaborators
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Systemic Sclerosis, Mouth Diseases
Keywords
Scleroderma, Systemic sclerosis, Mouth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation
Arm Type
Experimental
Arm Description
Cases will be evaluated for oral health and data will be recorded.
Intervention Type
Other
Intervention Name(s)
Evaluation
Intervention Description
The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.
Primary Outcome Measure Information:
Title
Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS)
Description
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.
Time Frame
at first day and second week change
Secondary Outcome Measure Information:
Title
Scleroderma Health Assessment Questionnaire (SHAQ)
Description
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.
Time Frame
at first day
Title
Oral Health Impact Profile (OHIP-14)
Description
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.
Time Frame
at first day
Title
Eating Assessment Tool (EAT-10)
Description
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.
Time Frame
at first day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA CIVI KARAASLAN, MSc
Organizational Affiliation
Research Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
İ̇stanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17502364
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.
Results Reference
background
PubMed Identifier
21847653
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.
Results Reference
background
PubMed Identifier
23881437
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.
Results Reference
background
PubMed Identifier
15055670
Citation
Scardina GA, Messina P. Systemic sclerosis: description and diagnostic role of the oral phenomena. Gen Dent. 2004 Jan-Feb;52(1):42-7.
Results Reference
background
PubMed Identifier
6587299
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.
Results Reference
background

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Mouth Handicap in Systemic Sclerosis

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