Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy Outcomes in Patients With Periodontitis: A Prospective Clinical and Microbial Study
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
- Probing depth changes
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 periodontal debridement.
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. Patients were enrolled from January 2020 to December 2022. The local ethical committee of approved the study protocol (125/PO) 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 will acquired from 4 separate proximal periodontal sites.
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
- 25 Years 至 65 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
Probing depth changes
时间窗: 6 months
Measurment of Probing Depth changes in millimeters
次要结局
未报告次要终点
研究者
Gaetano Isola
Researcher
University of Catania