Could gum bacteria fuel scleroderma? a new study digs in

NCT ID NCT06182293

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Scleroderma, systemic are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Clinique Dentaire

    RECRUITING

    Strasbourg, 67000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.