Could gum bacteria fuel scleroderma? a new study digs in
NCT ID NCT06182293
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This study investigates whether systemic sclerosis, a rare autoimmune disease, changes the community of bacteria living in the mouth. Researchers will collect dental plaque samples from 30 participants—some with scleroderma and some without—to compare the types and functions of oral microbes. The goal is to understand if these bacterial changes are linked to the disease, which could open doors to new insights or treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Subgingival dental plaque sampling for whole metagenome sequencing
- What this could lead to
- If successful, this could reveal how gum bacteria influence systemic sclerosis, potentially pointing toward new ways to manage the disease.
- What could go wrong
- This is a small pilot study, so findings may not apply broadly. It only observes, not tests a treatment, and cannot prove cause and effect.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Clinique Dentaire
RECRUITINGStrasbourg, 67000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Are women with autoimmune diseases getting the gynecological care they need?
- New shot aims to tame rare autoimmune disease
- Cancer drug shows promise for rare skin disease
- Scientists probe immune Cells' role in scleroderma blood vessel injury
- New drug hope for scleroderma patients with lung complications