Effect of Phytotherapy Agens in Non Surgical Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Clinical Attachment level
研究概览
简要总结
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence of the decontaminant tools for the management of Periodontitis (, the aim of this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with periodontitis, treated by either SRP in addition to phytotherapeutic drug or SRP alone.
详细描述
This trial was conducted in accordance with the World Medical Association's Declaration of Helsinki of 1975, and reviewed in 2008. The local ethical committee of the University of Messina approved the study protocol and each patient was carefully informed about the possible inherent risks of the study and provided their informed written consent 34 patients, 18 men and 16 women, aged 27 to 65 (mean age 44.2) were assessed for eligibility . In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after therapy.
The Gingival Crevicular Fluid (GCF) was gathered, at the same time from other four different non-contiguous interproximal sites using filter paper strips‡ as previously described. The levels of IL-1β, IL-10 and TNF-α were recognized by conventional enzyme-linked immunosorbent assay using an equation with software using a five polynomial parameter. Each selected subject underwent randomly, without anaesthesia, at the same time and after recording periodontal parameters, the two following treatments: in one, were treated as conventional Scaling and Root Planing (SRP) + phytotherapeutic drug (Neuridase), while the other group were treated as conventional SRP alone
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, Investigator)
入排标准
- 年龄范围
- 32 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good condition of general health,
- •a minimum of 2 teeth for each quadrant with a Pocket Depth (PD) ranging from 4-6 mm,
- •no involvement of the furcation,
- •a minimum of a six teeth per quadrant, respectively.
排除标准
- •periodontal therapy during the last 12 months,
- •assumption of antibiotics during the last 6 months,
- •any systemic condition which might affect the effects of the study treatment,
- •previous or current radiation or immunosuppressive therapies,
- •use of mouthwash containing antimicrobials during the previous 3 months,
- •no use of hormonal contraceptives,
- •medication by anti-inflammatory and immunosuppressive drugs,
- •previous history of hard-drinking,
- •class II and III tooth mobility.
结局指标
主要结局
Clinical Attachment level
时间窗: 180 days
Analysis of reduction of clinical attachment level
次要结局
未报告次要终点
研究者
Gaetano Isola, DDS, PhD
Assistant professor
University of Messina