- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07412431
Periodontal Health Profile in Multiple Sclerosis Patients
Evaluation of Periodontal Status in Patients With Multiple Sclerosis: A Clinical, Microbiological, and Biochemical Study
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Nuriye Işıl SAYGUN, Professor
- Phone Number: +903125671500
- Email: nuriyeisil.saygun@sbu.edu.tr
Study Contact Backup
- Name: Merve İNCEÖZ, Research Assistant
- Phone Number: +903125671500
- Email: merve.inceoz@sbu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria (Test Group):
- 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.
Inclusion Criteria (Control Group):
- 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.
Exclusion Criteria (Test Group):
- 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.
Exclusion Criteria (Control Group):
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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
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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.
|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary P.gingivalis Levels
Time Frame: Baseline
|
P.gingivalis in saliva samples using Real-time PCR to assess their correlation with MS disease status.
|
Baseline
|
|
Salivary F.nucleatum Levels
Time Frame: Baseline
|
F.nucleatum in saliva samples using Real-time PCR to assess their correlation with MS disease status.
|
Baseline
|
|
Salivary EBV Levels
Time Frame: Baseline
|
EBV in saliva samples using Real-time PCR to assess their correlation with MS disease status.
|
Baseline
|
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Salivary IL-17 Levels
Time Frame: Baseline
|
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.
|
Baseline
|
|
Salivary IL-11 Levels
Time Frame: Baseline
|
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.
|
Baseline
|
|
Salivary TNF-alpha Levels
Time Frame: Baseline
|
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.
|
Baseline
|
|
Salivary SIRT-1 Levels
Time Frame: Baseline
|
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.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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