NCT04273386

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 2, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2022

Completed
Last Updated

April 13, 2022

Status Verified

April 1, 2022

Enrollment Period

2.2 years

First QC Date

November 26, 2019

Last Update Submit

April 12, 2022

Conditions

SclerodermaSystemic SclerosisMouth Diseases

Keywords

SclerodermaSystemic sclerosisMouth

Outcome Measures

Primary Outcomes (1)

  • 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.

    at first day and second week change

Secondary Outcomes (3)

  • Scleroderma Health Assessment Questionnaire (SHAQ)

    at first day

  • Oral Health Impact Profile (OHIP-14)

    at first day

  • Eating Assessment Tool (EAT-10)

    at first day

Study Arms (1)

Evaluation

EXPERIMENTAL

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

Other: Evaluation

Interventions

EvaluationOTHER

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

Evaluation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be diagnosed with systemic sclerosis
  • Stability of medical treatments
  • Turkish literacy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 17502364BACKGROUND

  • 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.

    PMID: 21847653BACKGROUND

  • 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.

    PMID: 23881437BACKGROUND

  • Scardina GA, Messina P. Systemic sclerosis: description and diagnostic role of the oral phenomena. Gen Dent. 2004 Jan-Feb;52(1):42-7.

    PMID: 15055670BACKGROUND

  • 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.

    PMID: 6587299BACKGROUND

MeSH Terms

Conditions

Scleroderma, DiffuseScleroderma, SystemicMouth Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesStomatognathic Diseases

Study Officials

  • TUGBA CIVI KARAASLAN, MSc

    Research Assistant

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 26, 2019

First Posted

February 18, 2020

Study Start

December 2, 2019

Primary Completion

March 2, 2022

Study Completion

March 20, 2022

Last Updated

April 13, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)