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临床试验/NCT07412431
NCT07412431尚未招募不适用

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

Saglik Bilimleri Universitesi0 个研究点目标入组 100 人开始时间: 2026年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Clinical Attachment Level (CAL)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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.

排除标准

  • (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.

研究组 & 干预措施

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.

结局指标

主要结局

Clinical Attachment Level (CAL)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NURIYE ISIL SAYGUN

Professor

Saglik Bilimleri Universitesi

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