Effectiveness of an Oral Decontaminant Agent in Addition to Non-surgical Therapy of Chronic Periodontitis: A Split Mouth Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Probing depth (PD)
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 Chronic Periodontitis (cp), the aim of this study was to evaluates, at 1 year follow-up, the post-treatment clinical parameters and immunological and gingival microbial profiles in patients with CP, treated by either SRP in addition to desiccant or SRP alone.
The null hypothesis to invalidate was that, after a one year follow-up, there were no variations, in relation to clinical, anti-microbial and anti-inflammatory parameters between SRP + desiccant and SRP alone treatment.
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. Subjects with a diagnosis of CP (Chronic Periodontitis) were enrolled in this clinical trial.
Study design Thirty-six patients, 19 men and 17 women, aged 27 to 65 (mean age 46.7) were assessed for eligibility at the Department of Biomedical, Odontostomatological Sciences and Morphological and Functional Images at the University of Messina, Messina, Italy. This trial was conducted in agreement with the CONSORT guidelines.
In all subjects, subgingival plaque was acquired from 4 separate proximal sites at 365 days after therapy.
To permit the noninvasive specimen, all the sites chosen for analysis were isolated using cotton rolls. Subsequently, by one #40 sterilized paper point present in the commercial kit† introduced into the base of the selected site for 30 s, a subgingival plaque sample was collected.
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.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 61 Years（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 (PD)
时间窗: At 365 days
Measured clinically in mm using a periodontal probe during periodontal chart
次要结局
- Plaque and Gingival Crevicular Fluid(At 365 days)
研究者
Dr. Gaeasno Isola
DDS,PhD Dr. Isola Gaetano
University of Messina