Investigation of the Host Modulator Efficacy of Food Supplement Containing Hydrolyzed Collagen in Non-Surgical Periodontal Treatment of Patients With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- probing pocket depth
研究概览
简要总结
This study was planned on the basis of the hypothesis that 'food supplements containing collagen will support the clinical effectiveness of non-surgical periodontal therapy'. In this context, the aim of the study is to investigate the therapeutic efficacy of collagen-containing food supplement as a host modulation agent in the non-surgical periodontal treatment of individuals with stage 3-4 periodontitis in a clinical and biochemical manner in a comprehensive manner.
Initial day: Anamnesis, diagnosis and index measurements 2 days later, collection of serum samples from the patient, oral hygiene training and straightening of the whole mouth root surface and cleaning of the whole mouth tooth surface The next day, full mouth scalling and root planing are closed with the second session and tablets are started.
End of 2nd month:
Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
End of 6th month Periodontal index measurement and oral hygiene training Collecting serum and tissue samples 2 days later
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 60 age
- •stage 3-4 periodontitis
排除标准
- •Patients who smoke more than 10 cigarettes a day
- •Patients using immunosuppressive, oral contraceptive, bisphosphonate drugs
- •Patients who are during pregnancy or lactation
- •Having undergone periodontal treatment in the last 6 months, having used antibiotic anti-inflammatory medication in the last 4 weeks
- •The presence of any autoimmune disease, osteoporotic disease or cancer disease
- •Patients with renal and hepatic insufficiency
- •Patients with thyroid dysfunction
- •The presence of active infectious diseases(acute hepatitis, tuberculosis, AIDS)
- •Chronic drug use affecting periodontal tissues(cyclosporine A, Phenytoin)
- •Intake of antioxidant supplements
结局指标
主要结局
probing pocket depth
时间窗: baseline, 1st month and 3rd month
The distance between the gingival margin and the pocket base was measured in millimeters.
clinical attachment loss
时间窗: baseline, 1st month and 3th month
The distance from the enamel-cementum junction to the pocket base was measured in millimeters.
次要结局
- assessment of interleukin-1 beta levels(baseline, 1st month and 3th month)
- assessment of matrix metalloproteinase-8 (MMP-8) levels(baseline, 1st month and 3 th month)
研究者
Hatice Yemenoglu
assistant professor
Recep Tayyip Erdogan University