Mouth bacteria in systemic sclerosis
Impact of Systemic Sclerosis on the Periodontal Microbiota: a Pilot Study
This project will test whether the bacteria living under the gums differ in adults with early systemic sclerosis compared with routine dental patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06182293 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 with a diagnosis of systemic sclerosis made within the past two years, who have more than 12 teeth, are able to consent, and are affiliated with a social health insurance plan are ideal candidates.
Not a fit: People without enough natural teeth (fewer than 12), those with long-standing systemic sclerosis diagnosed more than two years ago, pregnant or breastfeeding individuals, or those unable to consent are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the study could identify specific gum bacterial patterns that help explain disease triggers or point to new prevention or treatment strategies.
How similar studies have performed: While gut microbiota alterations have been reported in systemic sclerosis, direct study of the periodontal microbiota in this disease is limited, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Strasbourg
- Clinique Dentaire — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Sophie JUNG, MD
- Email: sophie.jung1@chru-strasbourg.fr
- Phone: 03.88.11.69.10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.