Sjögren SyndromeCB-SJONCT04848870
Dental and Periodontal Status of Patients With Sjögren's Syndrome.
An observational study of Sjögren Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands.The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been shown in Sjögren's patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren Syndrome
- What is being tested?
- Salivary samples
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2022to 12 Jan 2032
- Phase
- Observational
- 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
Study population: The source population consists of patients coming to consult in the oral medicine department of the Hospital of the AP-HP Charles Foix (Ivry/seine), in a specialized consultation for patients with Sjögren Gougerot syndrome created in collaboration with the Reference Center for Rare Immune Auto Diseases (including Sjögren) of the Rheumatology Department of the Bicêtre Hospital. And patients followed in the oral medicine department of the AP-HP Charles Foix Hospital (Ivry/Seine) following oral care after the oral assessment at the Sjogren consultation
Who may be able to join
- Patient with Sjögren Syndrome
- Patient > 18 years old
- Patient affiliated to a social security system, beneficiary or beneficiary of a right other than AME
- Patient who speaks and understands French well enough to be able to read and understand the study information note.
- Patient who does not object to his participation in the study
Who cannot join
- Patient having expressed his opposition to participate in the research
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
Service de Médecine bucco-dentaire
Ivry-sur-Seine, Île-de-France Region, 94200
Marjolaine Gosset, Professor, +3369393901, marjolaine.gosset@aphp.fr
Franck Decup, Doctor, franck.decup@parisdescartes.fr
About this study
Official title: Prevalence and Characteristics of Dental and Periodontal Lesions in Patients With Sjögren's Syndrome. Establishment of a Biological Saliva Collection.
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands.The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been shown in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, although this has not been clearly identified in the literature.
Our main objective is to assess the prevalence of dental wear and gingival recession in patients with Sjögren's syndrome by analyzing of the Basic Erosive Wear Examination (BEWE) score for erosions, Basic Erosive Wear Abrasion (BEWA) score for attrition and percentage of sites with periodontal recessions greater than 3 mm in relation to the total number of sites.
Read more
Our secondary objectives are to investigate a correlation between the prevalence of dental and gingival wear, gingival inflammation, Decayed, Missing, and Filled Teeth (DMFT) index and (1) salivary parameters and (2) oral quality of life.
The salivary samples will be kept in a biological collection within the URP2496 for later analysis (biological collection CB-SJO).
Read the detailed description
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands leading to hyposiala. The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been described in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, but not clinical attachment loss, although this has not been clearly identified in the literature.
The present research focuses on the characterization of tooth wear and gingival recession prevalence in patients with Sjögren syndrome. A correlation of this parameters with salivary parameters (Xerostomia Inventory to assess the dryness, unstimulated salivary rate, stimulated salivary rate, pH and buffer capacity) will be assessed.
The salivary samples will be kept in a biological collection within the URP2496 for later cross-sectional research purposes to identify salivary changes associated with increased risk of dental wear, dental caries, periodontal wear or periodontal inflammation (biological collection CB-SJO).
This is a descriptive, prospective, open-label, non-interventional, single-center study with collection of salivary samples (CB-SJO) from a sample of patients with Sjögren's disease as part of the patient's routine care.
Patients will be recruited in the oral medicine department of the AP-HP Charles Foix hospital (Ivry/seine).
The time-line of the research is consistent with the usual patient management in oral medicine department. As Sjogren is a rare disease, we plan an inclusion period of 60 months. There is 60 months (i.e. 5 years) of follow-up, this means a total research duration of 120 months (i.e. 10 years)
- Conditions
- Sjögren Syndrome
- Being tested
- Salivary samples
- Keywords
- Sjögren syndrome, tooth wear, gingival recession
- Medical subject headings
- Sjogren's Syndrome, Tooth Wear, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary samplesOther
collection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA
| Study group | Role | What they receive |
|---|---|---|
| Sjögren patients | Patients in specialized consultations for Sjögren's patients in the oral medicine department of the Charles Foix Hospital AP-HP France Receives: Other: Salivary samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dental wear and gingival recession in patients with Sjögren Syndrome
BEWE score, BEWA score, Percentage of sites with periodontal recessions greater than 3 mm of the total number of sites
Measured: Once a year for 5 years
Secondary outcomes (3)
Correlation between the prevalence of dental wear and gingival recession and (1) salivary parameters and (2) oral quality of life
OHIP-14 for the oral quality of life assessment; measure of stimulated and unstimulated flow rate, pH and buffer capacity.; measure of the oral dryness through Xerostomia Inventory
Measured: Once a year for 5 years
Correlation between severity of the gingival inflammation and (1) salivary parameters and (2) oral quality of life.
Gingival inflammation assessed using the Bleeding On Probing score
Measured: Once a year for 5 years
Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life
Carious disease assessed using the DFMT index
Measured: Once a year for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Jan 2022
- Primary completion12 Jan 2032 (estimated)
- Study completion12 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolaine GOSSET, PUPH, Principal investigator, Assistance Publique - Hôpitaux de ParisCatherine CHAUSSAIN, PUPH, Study director, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848870
- Sponsor's protocol ID
- APHP210258
- Acronym
- CB-SJO
- Status last verified
- Dec 2024
- First submitted
- 13 Apr 2021
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data (age, medical history, medication, dental brushing habits, tobacco consumption, periodontal charting, number of decayed teeth, number of teeth with fillings, number of missing teeth, BEWE score, salivary data, OHIP-14 and Xerostomia Inventory score) will be collected by the investigator on the Orbis medical record or on the paper CRF. They will be transferred by the investigator of the service or a co-investigator of the service on an anonymized excel database and will be sent by secured link for repatriation to the laboratory URP2496.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characteristics of Dental and Periodontal Lesions in Patients With Sjögren's Syndrome. Establishment of a Biological Saliva Collection.
- ClinicalTrials.gov ID
- NCT04848870
- Acronym / sponsor ID
- CB-SJO / APHP210258
- Conditions
- Sjögren Syndrome
- Keywords
- Sjögren syndrome, tooth wear, gingival recession
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 12 Jan 2032 (estimated)
- Study completion
- 12 Jan 2032 (estimated)
- First posted
- 19 Apr 2021 (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.
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands.The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been shown in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, although this has not been clearly identified in the literature.
Our main objective is to assess the prevalence of dental wear and gingival recession in patients with Sjögren's syndrome by analyzing of the Basic Erosive Wear Examination (BEWE) score for erosions, Basic Erosive Wear Abrasion (BEWA) score for attrition and percentage of sites with periodontal recessions greater than 3 mm in relation to the total number of sites.
Our secondary objectives are to investigate a correlation between the prevalence of dental and gingival wear, gingival inflammation, Decayed, Missing, and Filled Teeth (DMFT) index and (1) salivary parameters and (2) oral quality of life.
The salivary samples will be kept in a biological collection within the URP2496 for later analysis (biological collection CB-SJO).
Detailed description
Sjögren's syndrome (SS) is a rare chronic systemic autoimmune disease characterized by destruction of the exocrine glands, including the salivary glands leading to hyposiala. The lack of saliva exposes the patient to dental caries, and dental wear although this has rarely been described in Sjögren's patients. Moreover, these patients seem to have more inflammation and gingival recession, but not clinical attachment loss, although this has not been clearly identified in the literature.
The present research focuses on the characterization of tooth wear and gingival recession prevalence in patients with Sjögren syndrome. A correlation of this parameters with salivary parameters (Xerostomia Inventory to assess the dryness, unstimulated salivary rate, stimulated salivary rate, pH and buffer capacity) will be assessed.
The salivary samples will be kept in a biological collection within the URP2496 for later cross-sectional research purposes to identify salivary changes associated with increased risk of dental wear, dental caries, periodontal wear or periodontal inflammation (biological collection CB-SJO).
This is a descriptive, prospective, open-label, non-interventional, single-center study with collection of salivary samples (CB-SJO) from a sample of patients with Sjögren's disease as part of the patient's routine care.
Patients will be recruited in the oral medicine department of the AP-HP Charles Foix hospital (Ivry/seine).
The time-line of the research is consistent with the usual patient management in oral medicine department. As Sjogren is a rare disease, we plan an inclusion period of 60 months. There is 60 months (i.e. 5 years) of follow-up, this means a total research duration of 120 months (i.e. 10 years)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sjögren patients | – | Other: Salivary samplesPatients in specialized consultations for Sjögren's patients in the oral medicine department of the Charles Foix Hospital AP-HP France |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population consists of patients coming to consult in the oral medicine department of the Hospital of the AP-HP Charles Foix (Ivry/seine), in a specialized consultation for patients with Sjögren Gougerot syndrome created in collaboration with the Reference Center for Rare Immune Auto Diseases (including Sjögren) of the Rheumatology Department of the Bicêtre Hospital. And patients followed in the oral medicine department of the AP-HP Charles Foix Hospital (Ivry/Seine) following oral care after the oral assessment at the Sjogren consultation
Key inclusion criteria (5 listed)
- Patient with Sjögren Syndrome
- Patient > 18 years old
- Patient affiliated to a social security system, beneficiary or beneficiary of a right other than AME
- Patient who speaks and understands French well enough to be able to read and understand the study information note.
- Patient who does not object to his participation in the study
Key exclusion criteria (1 listed)
- Patient having expressed his opposition to participate in the research
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 |
|---|---|---|
| Salivary samplescollection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA | Other | Sjögren patients |
Primary outcome
Prevalence of dental wear and gingival recession in patients with Sjögren Syndrome
Time frame: Once a year for 5 years
BEWE score, BEWA score, Percentage of sites with periodontal recessions greater than 3 mm of the total number of sites
3 secondary outcomes
Correlation between the prevalence of dental wear and gingival recession and (1) salivary parameters and (2) oral quality of life
Time frame: Once a year for 5 years
Correlation between severity of the gingival inflammation and (1) salivary parameters and (2) oral quality of life.
Time frame: Once a year for 5 years
Correlation between severity of carious disease and (1) salivary parameters and (2) oral quality of life
Time frame: Once a year for 5 years
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 30 Dec 2024.
- Individual participant dataSharing planned: Yes. The data (age, medical history, medication, dental brushing habits, tobacco consumption, periodontal charting, number of decayed teeth, number of teeth with fillings, number of missing teeth, BEWE score, salivary data, OHIP-14 and Xerostomia Inventory score) will be collected by the investigator on the Orbis medical record or on the paper CRF. They will be transferred by the investigator of the service or a co-investigator of the service on an anonymized excel database and will be sent by secured link for repatriation to the laboratory URP2496.
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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.
Marjolaine GOSSET, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
Catherine CHAUSSAIN, PUPH study director
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren Syndrome, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 1 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 30 Dec 2024. 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 Marjolaine GOSSET, PU-PH (+33 6 19 39 39 01, marjolaine.gosset@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dental wear and gingival recession in patients with Sjögren Syndrome (time frame: Once a year for 5 years). 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 30 Dec 2024.