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NCT Number: NCT07412431

Periodontal Health Profile in Multiple Sclerosis Patients

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Mouth Diseases Nervous System Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Salivary P.gingivalis Levels

    Time frame: Baseline

    P.gingivalis in saliva samples using Real-time PCR to assess their correlation with MS disease status.

  2. Salivary F.nucleatum Levels

    Time frame: Baseline

    F.nucleatum in saliva samples using Real-time PCR to assess their correlation with MS disease status.

  3. Salivary EBV Levels

    Time frame: Baseline

    EBV in saliva samples using Real-time PCR to assess their correlation with MS disease status.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Merve İNCEÖZ, Research Assistant

CONTACT

[email protected]

+903125671500

Nuriye Işıl SAYGUN, Professor

CONTACT

[email protected]

+903125671500

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

Evaluation of Periodontal Status in Patients With Multiple Sclerosis: A Clinical, Microbiological, and Biochemical Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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