Clinical, Biochemical and Microbiological Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- changes in CAL (clinical attachment level in millimetres )
研究概览
简要总结
The aim of the planned randomized clinical trial will be the clinical and microbiological evaluation of the new intracellular drug developed in cooperation with the Chair and Department of Drug Form Technology of the Medical University and the Department and Department of Pharmaceutical Microbiology and Parasitology of the Medical University in Wrocław.
详细描述
Clinical trials will be conducted on 60 patients of the Department of Periodontology of the Medical University of Wrocław with 3rd or 4th degree generalized periodontitis, who will consent to participate in the research by signing the documentation approved by the Bioethics Committee of our University. The exclusion criteria will be: the presence of general diseases affecting the clinical condition of the periodontium, hypersensitivity to the drug used in the carrier system, lack of proper oral hygiene, active nicotinism and age over 65 years. The research will be carried out according to the scheme of parallel randomization and double-blinded trial in two groups of 30 people. All qualified patients will undergo an initial period of periodontal treatment and scaling / root planning.
In the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side, placebo with a change of side in every second patient. In the other group, the drug under evaluation or placebo will be used on one side, and the SRP treatment with alternation of sides on the other side for every second patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •stage- 3rd degree generalized periodontitis
- •stage 4th degree generalized periodontitis
排除标准
- •presence of general diseases affecting the clinical condition of the periodontium,
- •hypersensitivity to the drug used in the carrier system,
- •lack of proper oral hygiene
- •active nicotinism
- •age over 65 years
研究组 & 干预措施
scaling root planning
patients in this group will have a scaling root planing procedure only
干预措施: scaling root planing (Procedure)
scaling root planning with new local drug delivery
patients in this group will have a scaling root planing procedure and a drug administered
干预措施: new local drug delivery (Drug)
scaling root planning with new local drug delivery
patients in this group will have a scaling root planing procedure and a drug administered
干预措施: scaling root planing (Procedure)
结局指标
主要结局
changes in CAL (clinical attachment level in millimetres )
时间窗: 3 month
Change in clinical attachment level of periodontal pockets measured from the Cement-enamel junction to the bottom of the pocket in millimetres using periodontal probe
changes in PD (pocket depth in millimetres )
时间窗: 3 month
Change in depth of periodontal pockets measured from the bottom of the pocket to the edge of the gum in millimetres using periodontal probe
changes in microbiome (rt PCR test)
时间窗: 3 month
change in microbiological and biochemical parameters of pocket microbiome using PCR real time test 3 months after Local dryg delivery (LDD) application( taken from the gingival pocket with gingival fluid with a paper filter. There will be six bacterial strains and the bacterial total load assessed)
次要结局
未报告次要终点