Scleroderma SystemicPeriomicrossNCT06182293
Periodontal Microbiota in Systemic Sclerosis
A study testing Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota in people with Scleroderma Systemic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma Systemic
- What is being tested?
- Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 24 Oct 2024to 24 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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)
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Dentaire
Strasbourg, 67000
Sophie JUNG, MD
About this study
Official title: Impact of Systemic Sclerosis on the Periodontal Microbiota: a Pilot Study
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.
- Conditions
- Scleroderma Systemic
- Being tested
- Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiotaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis | Other | Not described Receives: Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota |
| Controls | Other | Not described Receives: Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity of the periodontal microbiota using Chao-1 index
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start24 Oct 2024
- Primary completion24 Oct 2027 (estimated)
- Study completion24 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182293
- Sponsor's protocol ID
- 9149
- Acronym
- Periomicross
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2023
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Systemic Sclerosis on the Periodontal Microbiota: a Pilot Study
- ClinicalTrials.gov ID
- NCT06182293
- Acronym / sponsor ID
- Periomicross / 9149
- Conditions
- Scleroderma Systemic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 24 Oct 2027 (estimated)
- Study completion
- 24 Oct 2027 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis | Other | Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota |
| Controls | Other | Other: Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiotaSubgingival 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. | Other | Controls, Systemic sclerosis |
Primary outcome
Alpha diversity of the periodontal microbiota using Chao-1 index
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subgingival dental plaque sampling for whole metagenome sequencing of the periodontal microbiota in people with Scleroderma Systemic, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie JUNG, MD (03.88.11.69.10, sophie.jung1@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha diversity of the periodontal microbiota using Chao-1 index (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.