The Effect of Levodopa-Benserazide Combination on Periodontal Status in Patients With Parkinson's Disease: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Salivary Inflammatory Cytokine
研究概览
简要总结
The aim of this study is to evaluate the effects of Levodopa-Benserazide drug combination on periodontal status and salivary cytokine levels in patients with Parkinson's disease. The study includes four groups: Parkinson's patients with periodontitis, periodontally healthy Parkinson's patients, participants without Parkinson's with periodontitis, and periodontally healthy participants without Parkinson's. Clinical periodontal parameters (Plaque Index, Gingival Index, Bleeding on Probing, Pocket Depth, and Clinical Attachment Loss) will be recorded. Unstimulated saliva samples will be collected to analyze the levels of TNF-alpha, RANTES, IL-10, IL-13, Total Oxidant Status (TOS), Total Antioxidant Status (TAS), and Malondialdehyde (MDA).
详细描述
Background and Rationale: Parkinson's Disease (PD) is a progressive neurodegenerative disorder characterized by the degeneration of dopaminergic neurons in the substantia nigra. Chronic inflammation and oxidative stress are considered significant factors in the progression of PD. Levodopa (L-DOPA), combined with Benserazide, remains the most effective pharmacological treatment for managing PD symptoms. Periodontitis is a chronic inflammatory disease that leads to the destruction of tooth-supporting tissues and is associated with elevated levels of local and systemic inflammatory cytokines such as TNF-alpha, IL-10, IL-13, and RANTES. Recent studies suggest a bidirectional relationship between systemic inflammation and neurodegenerative diseases. This study aims to evaluate the effects of the Levodopa-Benserazide drug combination on periodontal status and salivary inflammatory cytokine levels in patients with Parkinson's Disease.
Study Design and Setting: This cross-sectional, case-control study will be conducted in collaboration with the Department of Periodontology at the University of Health Sciences, Gulhane Faculty of Dentistry, and the Department of Neurology at Hacettepe University Faculty of Medicine.
Participants and Groups: The study will include a total of 136 participants divided into four groups (n=34 per group):
Parkinson's patients with periodontitis
Periodontally healthy Parkinson's patients
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Parkinson's Disease according to United Kingdom Parkinson's Disease Society Brain Bank Criteria (for study group).
- •Systemically healthy individuals (for control group).
- •Willingness to participate and sign informed consent.
排除标准
- •Active smoking.
- •Comprehensive periodontal treatment within the last month.
- •Oral, respiratory, or digestive system diseases within the last 3 months.
- •Fewer than 16 natural teeth.
- •Use of full or removable partial dentures.
- •Dementia or inability to provide consent.
- •Serious active illnesses or substance abuse.
- •Antibiotic treatment within the last 3 months.
- •Probiotic use within the last month.
- •Radiotherapy/chemotherapy within the last 6 months.
- •Use of oral antiseptics within the last month.
- •Diabetes mellitus.
研究组 & 干预措施
Control - Periodontitis
Systemically healthy participants (non-Parkinson) who have Periodontitis.
Control - Healthy
Systemically and periodontally healthy participants.
Parkinson's - Periodontitis
Patients diagnosed with Parkinson's Disease who also have Periodontitis.
Parkinson's - Healthy
Patients diagnosed with Parkinson's Disease who are periodontally healthy.
结局指标
主要结局
Salivary Inflammatory Cytokine
时间窗: Day 1
TNF-alpha,
Salivary Oxidative Stress Levels
时间窗: Day 1
Total Oxidant Status (TOS)
次要结局
- Clinical Periodontal Parameters(Day 1)
研究者
Özlem SARAÇ ATAGÜN
Assoc Prof Dr.
Saglik Bilimleri Universitesi