Periodontal Health Profile in Multiple Sclerosis Patients

February 11, 2026 updated by: NURIYE ISIL SAYGUN, Saglik Bilimleri Universitesi

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.

Study Overview

Status

Not yet recruiting

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

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 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
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 3, 2026

Primary Completion (Estimated)

October 5, 2026

Study Completion (Estimated)

March 9, 2027

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will not be shared to protect participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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