An interventional study of Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota in Scleroderma Systemic, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Basic science
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.
310 studies on the registry are indexed under Scleroderma, Diffuse; 76 are open to participants now.
This study's planned enrollment of 30 is below the median of 38 across 227 interventional studies indexed under Scleroderma, Diffuse.
Browse Scleroderma, Diffuse studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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Inclusion Criteria:
Common inclusion criteria
Inclusion criteria for systemic sclerosis patients
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota
Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota
Subgingival plaque will be collected at 6 sites using sterile curettes after removal of supragingival biofilm by brushing. After microbial DNA extraction, whole metagenome will be sequenced.
Alpha diversity of the periodontal microbiota using Chao-1 index
Time frame: Baseline
Plan to share: No
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University Hospital, Strasbourg, France →