NCT06182293Recruiting
Periodontal Microbiota in Systemic Sclerosis
Impact of Systemic Sclerosis on the Periodontal Microbiota: a Pilot Study
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Dec 2023
- Start date
- 24 Oct 2024
- Primary completion date
- 24 Oct 2027
- Lead sponsor
- University Hospital, Strasbourg, France
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06182293
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 24 Oct 2024 to the primary completion date, 24 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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…)
- 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
Other illness
- Progressive chronic illness other than systemic sclerosis
- Acute infection at inclusion
Lab values
- Other associated systemic auto-immune disease (Sjögren syndrome with positive serum anti-SSA and/or anti-SSB auto-antibodies, systemic lupus erythematosus…)
Other
- \- 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)
- Risk of infective endocarditis
Who the study is looking for
- 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
- 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)
- \- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine dental consultation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique Dentaire Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.