Efficacy of INERSAN in Patients With Chronic Periodontitis as Adjunctive to Full Mouth Disinfection: a Randomized, Double Masked, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2)
研究概览
简要总结
The purpose of this study is to evaluate beneficial effects of probiotic Lactobacillus brevis CD2 tablets in addition to the primary treatment for patients with chronic periodontitis (Full Mouth Disinfection), at local level and at systemic level.
详细描述
This study will be conducted as a double blind, randomized, parallel group, placebo controlled clinical trial, involving subjects of 21 years of age or older to evaluate the beneficial effects of INERSAN® tablets as the primary treatment for patients with chronic periodontitis.
Patients satisfying the "Inclusion criteria" will be enrolled into the study after explaining them the objective of the study and after taking their written consent.
The probiotic tablets used in the present study contain a single strain of Lactobacilli, Lactobacillus brevis CD2, as active component. The placebo will be a mix of sugars and salts used as excipients in the active formulation. The active study medication and Placebo will be identical in appearance and organoleptic properties. Study treatment will be started from the day of enrollment and continued for 6 weeks. The daily dose of trial product will be 5 tablets per day, one tablet to be taken every 2-3 hours. The tablets will be to be kept in mouth for it to dissolve by itself. A hot beverage (e.g.: tea, coffee, milk etc.) will not to be taken for at least half an hour before and after the medication since elevated temperature could inactivate the bacteria.
The study drug and placebo will be provided as per the randomization schedule, packed in patient specific packs, bearing patient number. The study being a double masked study, both the patient and the Investigator will be blinded during the entire course of the trial. A sealed copy of the randomization codes will be given to the Principal Investigator and will be directed to open and break the codes only at the event of adverse events after discussion with sponsor and the monitor.
Patients will be informed that they may withdraw from the study at any time for any reasons. The Investigator also has the right to withdraw patients from the study if it is in the best interest of the patient. The reason and date of discontinuation will to be clearly documented in the case report form for all patients who discontinued the study product prematurely.
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, Care Provider)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 21-70 years of age groups;
- •patients with chronic periodontitis in need of primary treatment;
- •patients with at least 20 fully erupted teeth;
- •patients ready to give written informed consent for participating in the trial;
- •patients agreeing to comply with the study protocol and instructions.
排除标准
- •Pregnant women and lactating mothers;
- •patients with debilitating systemic diseases;
- •patients in needs for prophylactic antibiotics;
- •patients treated with antibiotics within 30 days prior to enrollment into the study;
- •patients already participant any other clinical trial or participant other investigational drug, or food supplement, in the last 30 days;
- •patient having active periapical abscess or periodontal abscess or a history of acute necrotizing ulcerative gingivitis;
- •patients not willing to participate in the trial.
- •patients with psychiatric problems.
结局指标
主要结局
Comparison in saliva and gingival crevicular fluid samples of the levels of modulators of inflammatory reaction (interleukin 1beta, interleukin 10, prostaglandin 2)
时间窗: 6 weeks
Comparison in saliva samples of the levels of metabolic phenotype
时间窗: 6 weeks
Comparison in saliva and gingival crevicular fluid samples of the levels of Matrixmetalloproteinases (MMPs)
时间窗: 6 weeks
次要结局
- Comparison in saliva samples of the levels of lactoferrin(6 weeks)
- Comparison in breath samples of the levels of Volatile Sulfur Compounds (VSC)(hydrogen sulfide, methyl mercaptan, dimethyl sulfide)(6 weeks)
- Comparison in saliva samples of the levels of Nitric Oxide Synthase (NOS) activity;(6 weeks)
- Comparison in saliva samples of the levels of Arginine deiminase(6 weeks)
- Comparison in blood samples of the levels of Toll Like Receptor-2 and Toll Like Receptor-4 positive B-cells(6 weeks)
- Comparison in saliva and gingival crevicular fluid samples of the levels of subgingival bacteria (Aggregatibacter Actinomycetemcomitan, Porphyromonas gingivalis, Tannerella Forsythia, Treponema denticola)(6 weeks)
研究者
Enrico Marchetti
Adjunct Professor
University of L'Aquila