Non-surgical Treatment of Periodontitis With or Without the Adjunctive Treatment of Perisolv®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 主要终点
- probing pocket depth
研究概览
简要总结
The goal of the clinical trial is to compare adjunctive chemomechanical therapy with standard care regarding root planning in patients with periodontitis. The primary outcome is to measure pocket depth before and after treatment in the test, and control group respectively
Secondary outcomes:
- Bleeding on probing
- Plaque index
- Quality of life from standardized protocol
The hypothesis is that non- surgical mechanical treatment with chloramines in patients with periodontitis will show a better pocket closure after the treatment.
详细描述
Data from the clinical treatment were registered in patient records. In parallel, clinical data were documented in a study protocol and saved in a safe in accordance with standard operation procedure at the clinic.The protocol with medical records were not opened until the study was completed and only by authorized persons with access to the data in the study such as, principal investigator and statisticians.
Variables used in the study originates from an international working group in periodontology in 2018 (Papapanou PN, et al 2018). In accordance with the working group diagnosis of periodontitis should include pocket depth, bleeding, and bone loss (X-ray). Thus, in this study the primary outcomes were pocket depth and bleeding on probing.
To compare scaling and root planning in periodontitis with an adjunctive application to enhance the standard care; an active comparator (Control group) was compared with an experimental arm (Test group).
Patients were therefore randomized into a test or control group. Inclusion criteria
- At least four pathological pockets ≥ 5 mm and bleeding on probing Exclusion criteria
- Diabetes HbA1c >7.0, antibiotics 3 months before treatment, cortisone treatment and if needed prophylactic antibiotics
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 (Investigator, Outcomes Assessor)
盲法说明
Principal investigator and investigator (the periodontologists) were calibrated prior to the study.
Outcome assessments were performed separately by the periodontologists and blinded. The statisticians were also blinded.
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who agree to participate in the study and who also have at least 4 gingival pockets with probing depth ≥5 mm and which at the same time bleed on probing.
排除标准
- •Individuals with uncontrolled/difficult diabetes mellitus (HbA1c > 7.0)
- •Individuals who need antibiotic prophylaxis
- •Individuals taking medication with Prednisolone.
- •Individuals taking medication that has a known side effect, gingival hyperplasia
- •Individuals who took systemic antibiotics 3 months before the start of the study.
结局指标
主要结局
probing pocket depth
时间窗: 12 months
millimeter
次要结局
- bleeding on probing(12 months)
- plaque index(12 months)
研究者
Viveca Wallin Bengtsson
Principle investigator
Kristianstad University