Scleroderma, SystemicNCT02371005
Oral Manifestations of Systemic Sclerosis
A study testing Cone Beam Computed Tomography (CBCT) in people with Scleroderma, Systemic, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. As all connective tissues can be affected, this condition has multiple effects on the orofacial region. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- Cone Beam Computed Tomography (CBCT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Common inclusion criteria
- Males and females ≥ 18 years (18th birthday completed)
- Affiliation to a social security scheme
- Signed informed consent form prior to inclusion in the study
- More than 12 natural teeth suitable for evaluation
- Systemic sclerosis Inclusion criteria for control
- Subjet that underwent or must undergo an upper and a lower jaw bone Cone Beam Computed Tomography examination (impacted teeth assessment, implant treatment planning)
Who cannot join
- Common exclusion criteria
- Overt acute or chronic infection (HIV, viral hepatitis…) known at the time of the oral examination
- Progressive neoplasia or neoplasia diagnosed within 2 years prior to the study
- Ongoing antibiotic treatment or within 3 months before oral examination
- Individuals at risk of infective endocarditis
- Oral antiseptics within the week before oral examination (chlorhexidine mouthwashes…)
Show all 22Show fewer
- Periodontal specialized treatments, root scaling/root planning or periodontal surgical treatment within the year before oral examination
- Ongoing medical treatment inducing a significant modification of the gingival state (anti-epileptic drugs…)
- Smoking (≥ 10 cigarettes per day)
- Pregnancy female subjects (positive urine pregnancy test)
- Lactating female subjects
- Impossibility to provide accurate informations (emergency situation, comprehension difficulties…)
- Patient currently involved in an other clinical trial (drug) or in an exclusion period following participation in another clinical trial
- 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 (diabetes…)
- Immunosuppressive therapy during the last month
- Corticosteroid ≥10 mg/day during the last month
- Hematopoietic stem cell transplant recipient
- Another cause of skin sclerosis (radiotherapy on the oro-facial region…)
- Systemic chronic or evolutive illness at the time of the inclusion
- Progressive pathology involving the maxilla or the mandible at the time of the inclusion (tumor…)
- Ongoing treatment with corticsteroids or non-steroidal anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic Markers
Systemic sclerosis (SSc) is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. As all connective tissues can be affected, this condition has multiple effects on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc patients. Oral manifestations have a major impact on quality of life and require specific treatments that should be performed as early as possible.
Widening of the periodontal ligament space, that seems to be linked to an increased collagen synthesis, is one of the most common dental radiographic finding. However, this radiologic sign has been mostly studied on two-dimensional radiographs. The investigators have recently described in a patient suffering from SSc the existence of calcifications within the periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al., Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been observed before, could be part of the phenotypic spectrum of the disease, in particular when dystrophic calcinosis is associated. They could furthermore constitute a specific feature of SSc. However, this radiographic sign requires to be investigated in a largest number of patients.
Read more
Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that elevated CXCL4 serum levels correlate with disease complications, suggesting that this molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate with SSc severity. Gingival crevicular fluid can be easily collected from the gingival crevice surrounding the teeth and constitute an indicator of local but also systemic inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the identification of specific SSc biomarkers and allow a better comprehension of oral manifestations pathogenesis.
The aim of this case-control study is to characterize precisely the oral manifestations associated with SSc within the National Referral Center for Rare Autoimmune Diseases (Strasbourg, France) patient cohort in order to identify specific radiological, clinical and/or biological signs. Some of them could be correlated to the severity or to the prognosis of the disease. To the investigators knowledge it is the first study using tridimensional CBCT approach.
- Conditions
- Scleroderma, Systemic
- Being tested
- Cone Beam Computed Tomography (CBCT)
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed Tomography (CBCT)Radiation
| Study group | Role | What they receive |
|---|---|---|
| Measurement of the periodontal ligament space | Other | Evaluation of the width of the ligament in patients with SSc and comparison to the width found in control. Receives: Radiation: Cone Beam Computed Tomography (CBCT) |
| Radiographic analysis of oro-facial manifestations | Other | Establishment of a complete clinical phenotypic description of oral manifestations associated with SSc and comparison with the control group. Receives: Radiation: Cone Beam Computed Tomography (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the periodontal ligament space width at mid-root level on Cone Beam Computed Tomography (CBCT) axial views
Measured: Baseline
Secondary outcomes (1)
Radiographic analysis of oro-facial manifestations associated with systemic sclerosis using high-resolution volumetric Cone Beam Computed Tomography (CBCT) exploration
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2021
- Study completionJun 2021
Why it stopped: scleroderma patients were difficult to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie JUNG, Dental surgeon, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371005
- Sponsor's protocol ID
- 6026
- Status last verified
- Sep 2021
- First submitted
- 18 Feb 2015
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jung S, Gavriiloglou M, Severac F, Haumesser L, Sayeh A, Chatelus E, Martin T, Huck O. Influence of systemic sclerosis on periodontal health: A case-control study. J Clin Periodontol. 2023 Oct;50(10):1348-1359. doi: 10.1111/jcpe.13846. Epub 2023 Jul 11.
PubMed 37431838
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Manifestations of Systemic Sclerosis: Toward the Identification of New Prognostic Markers
- ClinicalTrials.gov ID
- NCT02371005
- Acronym / sponsor ID
- 6026
- Conditions
- Scleroderma, Systemic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: scleroderma patients were difficult to recruit
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 25 Feb 2015 (estimated)
- 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 multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. As all connective tissues can be affected, this condition has multiple effects on the orofacial region. Indeed, the latter is involved in approximately 80% of SSc patients. Oral manifestations have a major impact on quality of life and require specific treatments that should be performed as early as possible.
Widening of the periodontal ligament space, that seems to be linked to an increased collagen synthesis, is one of the most common dental radiographic finding. However, this radiologic sign has been mostly studied on two-dimensional radiographs. The investigators have recently described in a patient suffering from SSc the existence of calcifications within the periodontal ligament space using Cone Beam Computed Tomography (CBCT) approach (Jung et al., Oral Surg Oral Med Oral Pathol Oral Radiol 2013). Such calcifications, that have never been observed before, could be part of the phenotypic spectrum of the disease, in particular when dystrophic calcinosis is associated. They could furthermore constitute a specific feature of SSc. However, this radiographic sign requires to be investigated in a largest number of patients.
Several cytokines have been implicated in SSc pathogenesis. A recent study has revealed that elevated CXCL4 serum levels correlate with disease complications, suggesting that this molecule could be used as a prognostic biomarker. Increased IL-6 serum levels also correlate with SSc severity. Gingival crevicular fluid can be easily collected from the gingival crevice surrounding the teeth and constitute an indicator of local but also systemic inflammation. Analysis of gingival crevicular fluid cytokine profile could contribute to the identification of specific SSc biomarkers and allow a better comprehension of oral manifestations pathogenesis.
The aim of this case-control study is to characterize precisely the oral manifestations associated with SSc within the National Referral Center for Rare Autoimmune Diseases (Strasbourg, France) patient cohort in order to identify specific radiological, clinical and/or biological signs. Some of them could be correlated to the severity or to the prognosis of the disease. To the investigators knowledge it is the first study using tridimensional CBCT approach.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Measurement of the periodontal ligament space | Other | Radiation: Cone Beam Computed Tomography (CBCT)Evaluation of the width of the ligament in patients with SSc and comparison to the width found in control. |
| Radiographic analysis of oro-facial manifestations | Other | Radiation: Cone Beam Computed Tomography (CBCT)Establishment of a complete clinical phenotypic description of oral manifestations associated with SSc and comparison with the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Common inclusion criteria
- Males and females ≥ 18 years (18th birthday completed)
- Affiliation to a social security scheme
- Signed informed consent form prior to inclusion in the study
- More than 12 natural teeth suitable for evaluation
Key exclusion criteria (22 listed)
- Common exclusion criteria
- Overt acute or chronic infection (HIV, viral hepatitis…) known at the time of the oral examination
- Progressive neoplasia or neoplasia diagnosed within 2 years prior to the study
- Ongoing antibiotic treatment or within 3 months before oral examination
- Individuals at risk of infective endocarditis
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 |
|---|---|---|
| Cone Beam Computed Tomography (CBCT) | Radiation | Measurement of the periodontal ligament space, Radiographic analysis of oro-facial manifestations |
Primary outcome
Measurement of the periodontal ligament space width at mid-root level on Cone Beam Computed Tomography (CBCT) axial views
Time frame: Baseline
1 secondary outcome
Radiographic analysis of oro-facial manifestations associated with systemic sclerosis using high-resolution volumetric Cone Beam Computed Tomography (CBCT) exploration
Time frame: Baseline
Results and safety
The study was stopped early (reason given: scleroderma patients were difficult to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Derived from this study: PubMed 37431838Jung S, Gavriiloglou M, Severac F, Haumesser L, Sayeh A, Chatelus E, Martin T, Huck O. Influence of systemic sclerosis on periodontal health: A case-control study. J Clin Periodontol. 2023 Oct;50(10):1348-1359. doi: 10.1111/jcpe.13846. Epub 2023 Jul 11.
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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. This study is not recruiting at the moment.
Sophie JUNG, Dental surgeon principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cone Beam Computed Tomography (CBCT) 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 7 inclusion and 22 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: stopped early, as of the sponsor's last update on 20 Sep 2021. 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?
The study was stopped early (reason given: scleroderma patients were difficult to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the periodontal ligament space width at mid-root level on Cone Beam Computed Tomography (CBCT) axial views (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371005, which also lists 1 linked publication.
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 20 Sep 2021.