Multiple SclerosisNCT07412431
Periodontal Health Profile in Multiple Sclerosis Patients
An observational study of Multiple Sclerosis and Periodontitis, run by Saglik Bilimleri Universitesi.
Trial summary
This study aims to evaluate the periodontal status of patients with Multiple Sclerosis (MS) through clinical, microbiological, and biochemical parameters. Multiple sclerosis and periodontal diseases are both chronic inflammatory conditions that may share common immunopathological pathways. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Periodontitis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 3 Feb 2026to 9 Mar 2027
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients diagnosed with Multiple Sclerosis who are followed by the Neurology Department of Ankara Bilkent City Hospital, and age-and-gender-matched systemically healthy volunteers as a control group.
Who may be able to join
- Voluntarily agreeing to participate in the study.
- Being over 18 years of age.
- Diagnosed with Multiple Sclerosis (MS) according to the 2017 McDonald criteria.
- Being able to communicate clearly and effectively.
- Voluntarily agreeing to participate in the study.
- Being over 18 years of age.
- Not having a diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald criteria.
- Being able to communicate clearly and effectively.
Who cannot join
- Being under 18 years of age.
- Patients whose MS diagnosis is not yet definitive.
- Being pregnant or in the lactation (breastfeeding) period.
- Having received antibiotic treatment within the last 3 months.
- Having received periodontal treatment within the last 6 months.
- Patients undergoing radiotherapy or chemotherapy.
Show all 12Show fewer
- Being under 18 years of age.
- Being diagnosed with Multiple Sclerosis (MS) according to the 2017 McDonald criteria.
- Being pregnant or in the lactation (breastfeeding) period.
- Having received antibiotic treatment within the last 3 months.
- Having received periodontal treatment within the last 6 months.
- Patients undergoing radiotherapy or chemotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Periodontal Status in Patients With Multiple Sclerosis: A Clinical, Microbiological, and Biochemical Study
This study aims to evaluate the periodontal status of patients with Multiple Sclerosis (MS) through clinical, microbiological, and biochemical parameters. Multiple sclerosis and periodontal diseases are both chronic inflammatory conditions that may share common immunopathological pathways. The primary objective is to investigate the relationship between MS and periodontal health by comparing clinical measurements with the microbial composition and biochemical markers found in saliva samples of patients followed by the Neurology Department.
Read the detailed description
The research is designed as a multidimensional study involving patients from the Neurology and Periodontology Departments. Participants will undergo a comprehensive periodontal examination to record clinical parameters (such as probing depth, clinical attachment level, and bleeding on probing). In addition to clinical assessments, the study includes:
Saliva Collection and Analysis: Whole unstimulated saliva samples will be collected from all participants under standardized conditions.
Microbiological Evaluation: The collected saliva will be analyzed to determine the microbial profile and identify specific periodontal pathogens associated with MS.
Biochemical Evaluation: Salivary samples will be further analyzed for biochemical markers (such as inflammatory cytokines or enzymes) to evaluate their role in the relationship between systemic inflammation in MS and oral health.
The study will be conducted at the Health Sciences University Gulhane Faculty of Dentistry and Ankara Bilkent City Hospital to provide a thorough understanding of how MS affects the oral ecosystem.
- Conditions
- Multiple Sclerosis, Periodontitis
- Keywords
- multiple sclerosis, periodontal diseases, Microbiological, p.gingivalis, inflamation, host modulation
- Medical subject headings
- Multiple Sclerosis, Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Sclerosis - Clinical Health Periodontium | This group consists of patients diagnosed with Multiple Sclerosis (MS) based on clinical, biochemical, and radiological features according to the 2017 McDonald Criteria. The cohort includes various clinical types: Relapsing-Remitting (RRMS), Secondary Progressive (SPMS), Primary Progressive (PPMS), and Progressive-Relapsing (PRMS). The participants in this group must have a clinically healthy periodontium. The term clinically healthy should be adopted to cover the absence of (or very significant reduction in) clinical periodontal inflammation on either an anatomically intact periodontium or a reduced periodontium. Participants will undergo clinical periodontal examinations and provide saliva samples for microbiological and biochemical analysis | |
| Multiple Sclerosis - Periodontal Disease | This group consists of patients diagnosed with Multiple Sclerosis (MS) based on clinical, biochemical, and radiological features according to the 2017 McDonald Criteria. The cohort includes various clinical types: Relapsing-Remitting (RRMS), Secondary Progressive (SPMS), Primary Progressive (PPMS), and Progressive-Relapsing (PRMS). Periodontal disease comprises a spectrum of pathological conditions involving the tooth-supporting tissues, namely the gingiva, periodontal ligament, cementum, and alveolar bone. The disease often initially manifests as gingivitis, a plaque-induced and reversible inflammatory condition affecting a large proportion of the population. In the absence of appropriate management, gingivitis may advance to periodontitis, a chronic and destructive disorder marked by irreversible attachment loss, progressive alveolar bone resorption, and potential tooth loss. | |
| Systemically Health - Clinical Healthy Periodontium | This group consists of systemically healthy volunteers who do not have any systemic diseases, including Multiple Sclerosis. The participants in this group must have a clinically healthy periodontium. The term clinically healthy should be adopted to cover the absence of (or very significant reduction in) clinical periodontal inflammation on either an anatomically intact periodontium or a reduced periodontium. Participants will undergo clinical periodontal examinations and provide saliva samples for microbiological and biochemical analysis | |
| Systemically health - Periodontal Disease | This group consists of systemically healthy volunteers without any systemic diseases. However, these participants are diagnosed with periodontal disease (gingivitis or periodontitis). Periodontal disease comprises a spectrum of pathological conditions involving the tooth-supporting tissues, namely the gingiva, periodontal ligament, cementum, and alveolar bone. The disease often initially manifests as gingivitis, a plaque-induced and reversible inflammatory condition affecting a large proportion of the population. In the absence of appropriate management, gingivitis may advance to periodontitis, a chronic and destructive disorder marked by irreversible attachment loss, progressive alveolar bone resorption, and potential tooth loss. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Level (CAL)
Measurement of the distance from the cemento-enamel junction to the base of the periodontal pocket in millimeters. Higher values indicate greater attachment loss.
Measured: Baseline
Probing Pocket Depth (PPD)
Measurement of the distance from the gingival margin to the base of the periodontal pocket in millimeters using a periodontal probe.
Measured: Baseline
Plaque Index (PI)
An index used to assess the thickness of plaque at the gingival margin. It evaluates oral hygiene status on a scale from 0 to 3 for each tooth surface, measured according to the criteria of Silness and Löe.
Measured: Baseline
Gingival Index (GI)
A clinical index used to assess the severity of gingival inflammation and bleeding tendency. It evaluates the color, consistency, and bleeding of the gums on a scale from 0 to 3, measured according to the criteria of Silness and Löe.
Measured: Baseline
Secondary outcomes (7)
Salivary P.gingivalis Levels
P.gingivalis in saliva samples using Real-time PCR to assess their correlation with MS disease status.
Measured: Baseline
Salivary F.nucleatum Levels
F.nucleatum in saliva samples using Real-time PCR to assess their correlation with MS disease status.
Measured: Baseline
Salivary EBV Levels
EBV in saliva samples using Real-time PCR to assess their correlation with MS disease status.
Measured: Baseline
Salivary IL-17 Levels
The concentration of IL-17 in saliva samples will be measured to evaluate the Th17-mediated inflammatory response. IL-17 is a key pro-inflammatory cytokine linked to both the pathogenesis of Multiple Sclerosis (MS) and the severity of periodontal tissue destruction.
Measured: Baseline
Salivary IL-11 Levels
Concentration of IL-11 in saliva samples will be measured using the ELISA method. IL-11 is an anti-inflammatory cytokine from the IL-6 family; its levels will be evaluated to understand its potential regulatory role in periodontal inflammation and its systemic reflection in patients with Multiple Sclerosis.
Measured: Baseline
Salivary TNF-alpha Levels
The concentration of TNF-alpha in saliva samples will be quantified using the ELISA technique. As a potent pro-inflammatory cytokine, TNF-alpha levels will be analyzed to assess the degree of local inflammation in the oral cavity and its potential correlation with systemic inflammatory activity in patients with Multiple Sclerosis.
Measured: Baseline
Salivary SIRT-1 Levels
The concentration of SIRT-1 in saliva samples will be measured using the ELISA technique. SIRT-1 is a NAD+-dependent deacetylase known for its role in cellular homeostasis, neuroprotection, and anti-inflammatory pathways. This outcome aims to evaluate the potential of SIRT-1 as a biomarker for disease activity in Multiple Sclerosis and its association with periodontal health status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Feb 2026 (estimated)
- Primary completion5 Oct 2026 (estimated)
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURIYE ISIL SAYGUN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412431
- Sponsor's protocol ID
- 2025-405
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Periodontal Status in Patients With Multiple Sclerosis: A Clinical, Microbiological, and Biochemical Study
- ClinicalTrials.gov ID
- NCT07412431
- Acronym / sponsor ID
- 2025-405
- Conditions
- Multiple Sclerosis, Periodontitis
- Keywords
- multiple sclerosis, periodontal diseases, Microbiological, p.gingivalis, inflamation, host modulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 3 Feb 2026 (estimated)
- Primary completion
- 5 Oct 2026 (estimated)
- Study completion
- 9 Mar 2027 (estimated)
- First posted
- 17 Feb 2026 (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.
This study aims to evaluate the periodontal status of patients with Multiple Sclerosis (MS) through clinical, microbiological, and biochemical parameters. Multiple sclerosis and periodontal diseases are both chronic inflammatory conditions that may share common immunopathological pathways. The primary objective is to investigate the relationship between MS and periodontal health by comparing clinical measurements with the microbial composition and biochemical markers found in saliva samples of patients followed by the Neurology Department.
Detailed description
The research is designed as a multidimensional study involving patients from the Neurology and Periodontology Departments. Participants will undergo a comprehensive periodontal examination to record clinical parameters (such as probing depth, clinical attachment level, and bleeding on probing). In addition to clinical assessments, the study includes:
Saliva Collection and Analysis: Whole unstimulated saliva samples will be collected from all participants under standardized conditions.
Microbiological Evaluation: The collected saliva will be analyzed to determine the microbial profile and identify specific periodontal pathogens associated with MS.
Biochemical Evaluation: Salivary samples will be further analyzed for biochemical markers (such as inflammatory cytokines or enzymes) to evaluate their role in the relationship between systemic inflammation in MS and oral health.
The study will be conducted at the Health Sciences University Gulhane Faculty of Dentistry and Ankara Bilkent City Hospital to provide a thorough understanding of how MS affects the oral ecosystem.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Multiple Sclerosis - Clinical Health Periodontium | – | –This group consists of patients diagnosed with Multiple Sclerosis (MS) based on clinical, biochemical, and radiological features according to the 2017 McDonald Criteria. The cohort includes various clinical types: Relapsing-Remitting (RRMS), Secondary Progressive (SPMS), Primary Progressive (PPMS), and Progressive-Relapsing (PRMS). The participants in this group must have a clinically healthy periodontium. The term clinically healthy should be adopted to cover the absence of (or very significant reduction in) clinical periodontal inflammation on either an anatomically intact periodontium or a reduced periodontium. Participants will undergo clinical periodontal examinations and provide saliva samples for microbiological and biochemical analysis |
| Multiple Sclerosis - Periodontal Disease | – | –This group consists of patients diagnosed with Multiple Sclerosis (MS) based on clinical, biochemical, and radiological features according to the 2017 McDonald Criteria. The cohort includes various clinical types: Relapsing-Remitting (RRMS), Secondary Progressive (SPMS), Primary Progressive (PPMS), and Progressive-Relapsing (PRMS). Periodontal disease comprises a spectrum of pathological conditions involving the tooth-supporting tissues, namely the gingiva, periodontal ligament, cementum, and alveolar bone. The disease often initially manifests as gingivitis, a plaque-induced and reversible inflammatory condition affecting a large proportion of the population. In the absence of appropriate management, gingivitis may advance to periodontitis, a chronic and destructive disorder marked by irreversible attachment loss, progressive alveolar bone resorption, and potential tooth loss. |
| Systemically Health - Clinical Healthy Periodontium | – | –This group consists of systemically healthy volunteers who do not have any systemic diseases, including Multiple Sclerosis. The participants in this group must have a clinically healthy periodontium. The term clinically healthy should be adopted to cover the absence of (or very significant reduction in) clinical periodontal inflammation on either an anatomically intact periodontium or a reduced periodontium. Participants will undergo clinical periodontal examinations and provide saliva samples for microbiological and biochemical analysis |
| Systemically health - Periodontal Disease | – | –This group consists of systemically healthy volunteers without any systemic diseases. However, these participants are diagnosed with periodontal disease (gingivitis or periodontitis). Periodontal disease comprises a spectrum of pathological conditions involving the tooth-supporting tissues, namely the gingiva, periodontal ligament, cementum, and alveolar bone. The disease often initially manifests as gingivitis, a plaque-induced and reversible inflammatory condition affecting a large proportion of the population. In the absence of appropriate management, gingivitis may advance to periodontitis, a chronic and destructive disorder marked by irreversible attachment loss, progressive alveolar bone resorption, and potential tooth loss. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients diagnosed with Multiple Sclerosis who are followed by the Neurology Department of Ankara Bilkent City Hospital, and age-and-gender-matched systemically healthy volunteers as a control group.
Key inclusion criteria (8 listed)
- Voluntarily agreeing to participate in the study.
- Being over 18 years of age.
- Diagnosed with Multiple Sclerosis (MS) according to the 2017 McDonald criteria.
- Being able to communicate clearly and effectively.
- Voluntarily agreeing to participate in the study.
Key exclusion criteria (12 listed)
- Being under 18 years of age.
- Patients whose MS diagnosis is not yet definitive.
- Being pregnant or in the lactation (breastfeeding) period.
- Having received antibiotic treatment within the last 3 months.
- Having received periodontal treatment within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Attachment Level (CAL)
Time frame: Baseline
Measurement of the distance from the cemento-enamel junction to the base of the periodontal pocket in millimeters. Higher values indicate greater attachment loss.
Probing Pocket Depth (PPD)
Time frame: Baseline
Measurement of the distance from the gingival margin to the base of the periodontal pocket in millimeters using a periodontal probe.
Plaque Index (PI)
Time frame: Baseline
An index used to assess the thickness of plaque at the gingival margin. It evaluates oral hygiene status on a scale from 0 to 3 for each tooth surface, measured according to the criteria of Silness and Löe.
Gingival Index (GI)
Time frame: Baseline
A clinical index used to assess the severity of gingival inflammation and bleeding tendency. It evaluates the color, consistency, and bleeding of the gums on a scale from 0 to 3, measured according to the criteria of Silness and Löe.
7 secondary outcomes
Salivary P.gingivalis Levels
Time frame: Baseline
Salivary F.nucleatum Levels
Time frame: Baseline
Salivary EBV Levels
Time frame: Baseline
Salivary IL-17 Levels
Time frame: Baseline
Salivary IL-11 Levels
Time frame: Baseline
Salivary TNF-alpha Levels
Time frame: Baseline
Salivary SIRT-1 Levels
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 17 Feb 2026.
- Individual participant dataSharing planned: No. The individual participant data will not be shared to protect participant privacy.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Periodontitis, run by Saglik Bilimleri Universitesi.
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 12 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: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Nuriye Işıl SAYGUN, Professor (+903125671500, nuriyeisil.saygun@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment Level (CAL) (time frame: Baseline). The study lists 4 primary outcomes in all. 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 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.