Mouth bacteria in systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect subgingival dental plaque from adult participants and perform whole metagenome sequencing to profile the periodontal microbiota. The study compares patients diagnosed with systemic sclerosis within the past two years to control patients attending routine dental care at the University Hospital of Strasbourg. Eligible participants must be adults with more than 12 teeth and able to give informed consent; key exclusions include pregnancy and legal guardianship. Samples and sequence data will be analyzed to identify differences in microbial composition and potential dysbiosis linked to systemic sclerosis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Common inclusion criteria

* Men or women over 18 (adults)
* Affiliation to a social health insurance plan
* Subject able to understand the aims and risks of the research and to give signed informed consent form prior to the inclusion in the study
* More than 12 teeth suitable for evaluation

Inclusion criteria for systemic sclerosis patients

* Systemic sclerosis patient with a diagnosis based on the American College of Rheumatology/European League Against Rheumatism criteria (LeRoy et al., 1988 ; van den Hoogen et al., 2013)
* Diagnosis made during the 2 years preceding study inclusion (early form of the disease)

Inclusion criteria for controls

\- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine dental consultation

Exclusion Criteria:

* \- Subject under court protection
* Subject under guardianship or curatorship
* Pregnancy or breastfeeding
* Impossibility to provide accurate information (emergency situation, comprehension difficulties…)
* Subject currently involved in another clinical trial or in an exclusion period following participation in another clinical trial
* Smoking (≥ 10 cigarettes per day)
* Other associated systemic auto-immune disease (Sjögren syndrome with positive serum anti-SSA and/or anti-SSB auto-antibodies, systemic lupus erythematosus…)
* Progressive chronic illness other than systemic sclerosis
* Acute infection at inclusion
* Progressive cancer or cancer diagnosed within 2 years prior to the study
* Ongoing antibiotic and/or antifungal treatment or within 3 months prior to inclusion
* Probiotics and/or prebiotics intake within 3 months prior to inclusion
* Oral antiseptics within the week before inclusion (chlorhexidin mouthwashes…)
* Risk of infective endocarditis
* Corticosteroids ≥10 mg/day and/or proton pump inhibitors within 3 months prior to inclusion
* Previous hematopoietic stem cell transplantation
* Another cause of skin sclerosis (radiotherapy of the orofacial area…)
* Periodontal specialized treatments, root and/or periodontal surgical treatment and/or subgingival instrumentation within the year before inclusion

Where it's running

• Clinique Dentaire
  Strasbourg, France Recruiting

Study contacts

• Study coordinator: Sophie JUNG, MD
• Email: sophie.jung1@chru-strasbourg.fr
• Phone: 03.88.11.69.10

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.