SclerodermaNCT04273386
Mouth Handicap in Systemic Sclerosis
A study testing Evaluation in people with Scleroderma and Systemic Sclerosis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma, Systemic Sclerosis, Mouth Diseases
- What is being tested?
- Evaluation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2019to 20 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed with systemic sclerosis
- Stability of medical treatments
- Turkish literacy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.
Read the 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.
- Conditions
- Scleroderma, Systemic Sclerosis, Mouth Diseases
- Being tested
- Evaluation
- Keywords
- Scleroderma, Systemic sclerosis, Mouth
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic, Mouth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvaluationOther
The study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen.
| Study group | Role | What they receive |
|---|---|---|
| Evaluation | Experimental | Cases will be evaluated for oral health and data will be recorded. Receives: Other: Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at first day and second week change
Secondary outcomes (3)
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.
Measured: at first day
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.
Measured: at first day
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.
Measured: at first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start2 Dec 2019
- Primary completion2 Mar 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Tugba Civi Karaaslan, Istanbul University - Cerrahpasa
- Investigators
- TUGBA CIVI KARAASLAN, MSc, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273386
- Sponsor's protocol ID
- ISTANBULC1
- Status last verified
- Apr 2022
- First submitted
- 26 Nov 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17502364Maddali 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.
PubMed 21847653Schouffoer 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.
PubMed 23881437Scardina GA, Messina P. Systemic sclerosis: description and diagnostic role of the oral phenomena. Gen Dent. 2004 Jan-Feb;52(1):42-7.
PubMed 15055670Naylor 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.
PubMed 6587299
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mouth Handicap in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04273386
- Acronym / sponsor ID
- ISTANBULC1
- Conditions
- Scleroderma, Systemic Sclerosis, Mouth Diseases
- Keywords
- Scleroderma, Systemic sclerosis, Mouth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 20 Mar 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation | Experimental | Other: EvaluationCases will be evaluated for oral health and data will be recorded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be diagnosed with systemic sclerosis
- Stability of medical treatments
- Turkish literacy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvaluationThe study will be carried out with the method of filling the evaluation form which is printed on paper with ballpoint pen. | Other | Evaluation |
Primary outcome
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.
3 secondary outcomes
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: at first day
Oral Health Impact Profile (OHIP-14)
Time frame: at first day
Eating Assessment Tool (EAT-10)
Time frame: at first day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Background: PubMed 17502364Mouthon 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.
- Background: PubMed 21847653Maddali 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.
- Background: PubMed 23881437Schouffoer 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.
- Background: PubMed 15055670Scardina GA, Messina P. Systemic sclerosis: description and diagnostic role of the oral phenomena. Gen Dent. 2004 Jan-Feb;52(1):42-7.
- Background: PubMed 6587299Naylor 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUGBA CIVI KARAASLAN, MSc principal investigator
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation in people with Scleroderma and Systemic Sclerosis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth Handicap in Systemic Sclerosis Questionnaire (MHISS) (time frame: at first day and second week change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04273386, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022; AzTrials last refreshed its copy on 31 Oct 2026.