Oral Manifestations of Systemic Sclerosis
NCT02371005 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2021-09-20
Summary
Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. As all connective tissues can be affected, this condition has multiple effects on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc patients. Oral manifestations have a major impact on quality of life and require specific treatments that should be performed as early as possible.
Widening of the periodontal ligament space, that seems to be linked to an increased collagen synthesis, is one of the most common dental radiographic finding. However, this radiologic sign has been mostly studied on two-dimensional radiographs. The investigators have recently described in a patient suffering from SSc the existence of calcifications within the periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al., Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been observed before, could be part of the phenotypic spectrum of the disease, in particular when dystrophic calcinosis is associated. They could furthermore constitute a specific feature of SSc. However, this radiographic sign requires to be investigated in a largest number of patients.
Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that elevated CXCL4 serum levels correlate with disease complications, suggesting that this molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate with SSc severity. Gingival crevicular fluid can be easily collected from the gingival crevice surrounding the teeth and constitute an indicator of local but also systemic inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the identification of specific SSc biomarkers and allow a better comprehension of oral manifestations pathogenesis.
The aim of this case-control study is to characterize precisely the oral manifestations associated with SSc within the National Referral Center for Rare Autoimmune Diseases (Strasbourg, France) patient cohort in order to identify specific radiological, clinical and/or biological signs. Some of them could be correlated to the severity or to the prognosis of the disease. To the investigators knowledge it is the first study using tridimensional CBCT approach.
Conditions
- Scleroderma, Systemic
Interventions
- RADIATION
-
Cone Beam Computed Tomography (CBCT)
Sponsors & Collaborators
-
University Hospital, Strasbourg, France
lead OTHER
Principal Investigators
-
Sophie JUNG, Dental surgeon · Les Hôpitaux Universitaires de Strasbourg
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-06-30
- Primary Completion
- 2021-06-30
- Completion
- 2021-06-30
Countries
- France
Study Locations
More Related Trials
-
Role of Circulating Cytotoxic Lymphocytes in Endothelial Cell Injury in Systemic Sclerosis
NCT02636127 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
NCT07326033 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Cohort of Patients With Systemic Sclerosis Within the Framework of the RESO Reference Centre
NCT04265144 ·Status: RECRUITING ·Phase: NA
-
Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.
NCT05171114 ·Status: COMPLETED ·Phase: NA
-
Metabolomic Analysis of Systemic Sclerosis
NCT02298777 ·Status: TERMINATED
-
Stem Cell Factor, a Potential Biological Marker of Skin Involvement in Systemic Sclerosis?
NCT05482594 ·Status: UNKNOWN
-
Implementation of a Biological Sample Collection in Systemic Sclerosis Patients
NCT04986514 ·Status: WITHDRAWN
-
Oral Type I Collagen for Relieving Scleroderma
NCT00005675 ·Status: COMPLETED ·Phase: PHASE2
-
Mouth Handicap in Systemic Sclerosis
NCT04273386 ·Status: COMPLETED ·Phase: NA
-
Prevention and Treatment of Digital Ulcers in Systemic Sclerosis
NCT01836263 ·Status: UNKNOWN
-
Familial Systemic Scleroderma
NCT07343115 ·Status: RECRUITING
-
Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
NCT05177380 ·Status: UNKNOWN ·Phase: NA
-
Calcinosis in a Single-Center Scleroderma Population
NCT02062125 ·Status: COMPLETED
-
Evaluation of Calcinosis in Systemic Sclerosis
NCT03340194 ·Status: COMPLETED
-
What is the Optimal Follow-up for Patients With Systemic Sclerosis?
NCT05103553 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Periodontal Microbiota in Systemic Sclerosis
NCT06182293 ·Status: RECRUITING ·Phase: NA
-
Western Sweden Systemic Sclerosis Project
NCT07345052 ·Status: RECRUITING
-
Diffuse Cutaneous Scleroderma (DSSc) SFDI Study
NCT07090226 ·Status: RECRUITING ·Phase: NA
-
Analysis of Dermal Fibroblasts and Immune Cells During Systemic Sclerosis
NCT05273138 ·Status: RECRUITING
-
Prevalence of Hyperprolactinemia in Systemic Scleroderma
NCT04746313 ·Status: COMPLETED
-
SCLERoderma et Adipose-DErived Stroma Cells
NCT02866552 ·Status: UNKNOWN ·Phase: PHASE2
-
Examining the Immunological Process of Autoimmune Patients
NCT02123147 ·Status: WITHDRAWN
-
Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis
NCT04996082 ·Status: COMPLETED
-
Development and Prevention of Severe Heart Disease in Systemic Sclerosis
NCT01829126 ·Status: UNKNOWN
-
AUTOANTIBODIES AND SYSTEMIC SCLEROSIS
NCT06502678 ·Status: NOT_YET_RECRUITING