Evaluation of Periodontal Status in Patients With Multiple Sclerosis: A Clinical, Microbiological, and Biochemical Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 100
- Primary Endpoint
- Clinical Attachment Level (CAL)
Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Salivary P.gingivalis Levels(Baseline)
- Salivary F.nucleatum Levels(Baseline)
- Salivary EBV Levels(Baseline)
- Salivary IL-17 Levels(Baseline)
- Salivary IL-11 Levels(Baseline)
- Salivary TNF-alpha Levels(Baseline)
- Salivary SIRT-1 Levels(Baseline)
Investigators
NURIYE ISIL SAYGUN
Professor
Saglik Bilimleri Universitesi