Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06182293

Periodontal Microbiota in Systemic Sclerosis

Led by University Hospital, Strasbourg, France · Updated on 2025-08-06

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential triggers of SSc in individuals with a permissive genetic background. Patients show a wide spectrum of clinical features including periodontitis, which is an inflammatory disease of the tooth-supporting tissues resulting from dysbiosis of the periodontal microbiota guided by inflammophilic bacteria. The microbiota plays a fundamental role in the induction, training, and function of the host immune system. Numerous studies have highlighted the impact of an altered microbiota, i.e. dysbiosis, on the pathogenesis of immune-mediated diseases. Indeed, commensals are important to maintain immune homeostasis and changes in the microbial composition can be responsible for a loss of tolerance. SSc has been shown to be associated with gut dysbiosis and a depletion of commensals. However, although the oral cavity is one of the two largest microbial habitats, only one study (only focusing on Lactobacillus species) has investigated the oral microbiota in SSc. As periodontal dysbiosis is known to induce low-grade systemic inflammation and represents a risk factor for the development of various autoimmune diseases, the relationship between periodontal microbiota composition and SSc merits further exploration. The aim of this pilot study is to characterize the taxonomic composition and metabolic pathways of the periodontal microbiota in SSc patients and age and sex-matched controls.

CONDITIONS

Official Title

Periodontal Microbiota in Systemic Sclerosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women over 18 years old
  • Affiliated to a social health insurance plan
  • Able to understand the study and provide signed informed consent
  • Have more than 12 teeth suitable for evaluation
  • Systemic sclerosis diagnosis based on American College of Rheumatology/European League Against Rheumatism criteria
  • Diagnosis made within 2 years before study inclusion for systemic sclerosis patients
  • Controls attending routine dental consultation at University Hospital of Strasbourg Oral Medicine and Surgery Department
Not Eligible

You will not qualify if you...

  • Under court protection, guardianship, or curatorship
  • Pregnant or breastfeeding
  • Unable to provide accurate information due to emergency or comprehension difficulties
  • Currently in another clinical trial or within exclusion period after another trial
  • Smoking 10 or more cigarettes per day
  • Have other systemic autoimmune diseases (e.g., Sjögren syndrome with positive anti-SSA/SSB, systemic lupus erythematosus)
  • Progressive chronic illness other than systemic sclerosis
  • Acute infection at inclusion
  • Progressive cancer or cancer diagnosed within 2 years prior
  • Ongoing or recent (within 3 months) antibiotic or antifungal treatment
  • Probiotics or prebiotics intake within 3 months prior
  • Oral antiseptics use within the week before inclusion
  • Risk of infective endocarditis
  • Use of corticosteroids ≥10 mg/day or proton pump inhibitors within 3 months prior
  • Previous hematopoietic stem cell transplantation
  • Another cause of skin sclerosis (e.g., radiotherapy to orofacial area)
  • Periodontal specialized treatments, root or periodontal surgery, or subgingival instrumentation within 1 year before inclusion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinique Dentaire

Strasbourg, France, 67000

Actively Recruiting

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Research Team

S

Sophie JUNG, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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Periodontal Microbiota in Systemic Sclerosis | DecenTrialz