Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 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 protocols 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 full mouth scaling or quadrant scaling
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 88 patients, aged 27 to 65 (mean age 57) were assessed for eligibility. In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 180 days after therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Both participants and clinicians were blinded to group and treatment assignment
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of at least 15 teeth
- •CP with a minimum of 40% of sites with a clinical attachment level (CAL)
- •≥2mm and probing depth (PD) ≥4mm;
- •Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- •Presence of ≥40% sites with bleeding on probing (BOP)
排除标准
- •Intake of contraceptives
- •Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- •Status of pregnancy or lactation
- •Previous history of excessive drinking
- •Allergy to local anaesthetic
- •Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
结局指标
主要结局
Clinical attachment level
时间窗: 1-year
evaluation of changes in clinical attachment level
次要结局
未报告次要终点
研究者
Gaetano Isola
Researcher
University of Catania