Clinical Trial: Oral Manifestations of Systemic Sclerosis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Oral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic Markers

Brief 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 coul

Detailed Summary:
Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Measurement of the periodontal ligament space width at mid-root level on Cone Beam Computed Tomography (CBCT) axial views [ Time Frame: Baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Radiographic analysis of oro-facial manifestations associated with systemic sclerosis using high-resolution volumetric Cone Beam Computed Tomography (CBCT) exploration [ Time Frame: Baseline ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: February 18, 2015
Date Started: June 2015
Date Completion: June 2015
Last Updated: February 24, 2015
Last Verified: February 2015