Antimicrobial and Anti-inflammatory Effects of Simvastatin as an Intracanal Medication in Endodontically Retreated Teeth With Periapical Radiolucency, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Simvastatin antimicrobial effect
研究概览
简要总结
Successful endodontic treatment and a predictable outcome can only be achieved by effective root canal debridement, irrigation, and elimination of microorganisms .
The outcome of endodontic treatment performed in controlled clinical environment has demonstrated success rate around 90%.
In certain cases, endodontic treatment may fail, one of the most common reasons is inability to eliminate microorganisms from the root canal. When non-surgical root canal therapy fails, the treatment options include orthograde re-treatment, periradicular surgery, or extraction.
Simvastatin (SIM) is a drug used primarily to treat hyperlipidemia and protect against cardiovascular diseases. It has been shown to possess pleiotropic effects such as antimicrobial, anti-inflammatory, immunomodulatory, antioxidant, and bone-forming properties .
The side chain of this material has a single methyl group. It inhibits hydroxymethyl glutarylcoenzyme reductase that prevents endogenous cholesterol synthesis
详细描述
It has been reported that the inflamed/infected periodontal/endodontic content influence cytokines release . These inflammatory mediators, such as interleukin (IL)-1β, tumor necrosis factor α (TNF-α), and prostaglandin E2 (PGE2), have been detected in periapical tissues and root canal exudates .
Proinflammatory cytokines are able to stimulate, either directly or indirectly, the release of matrix metalloproteinases (MMPs) in the periapical/periodontal region, maintaining a persistent inflammatory process. MMPs are deeply involved in the pathogenesis of pulp, periodontal, and periapical tissue destruction.
As a Gram-positive, facultative anaerobe, Enterococcus Faecalis (E. Faecalis) can survive root canal treatment . It can form biofilms and survive prolonged periods of nutritional deprivation. It can also resist acidic and basic conditions and is hard to eradicate .
E. Faecalis is responsible for 20-70% of endodontic failures and secondary endodontic infections . Due to biofilm development and the organism's physicochemical characteristics, which enable it to alter the prevailing environmental and nutritional conditions, it can even thrive in constrained environments .
Accumulated evidence indicates that the tissue destruction in endodontic and periodontal infections is due to host-derived cytokines induced by lipopolysaccharides (LPS/endotoxins), acting as the major components of the outer leaflet of the outer membrane of gram-negative bacteria.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had anon contributory medical history.
- •Patients of age categories between 20 to 40 years old, with no physical disability or psychological problems.
- •Single rooted teeth with type I root canal anatomy.
- •Symptomatic cases of failed endodontic treatment with radiographic evidence of periapical bone loss, and the lesion size ranging from 2mm up to 8mm.
排除标准
- •Patients with known sensitivity to the pharmaceutical used in this trial
- •Patients with former endodontic mishaps (as ledges, transportations, perforations or separated instruments)
- •Non restorable teeth
- •Presence of an associated sinus tract.
- •Advanced periodontal involvement
- •Teeth representing root fracture.
- •Pregnant women
结局指标
主要结局
Simvastatin antimicrobial effect
时间窗: 6 Months
Following the treatment, patients will be asked to evaluate The antimicrobial effect of Simvastatin intracanal medication
次要结局
- Simvastatin anti-inflammatory effect(6 Months)
研究者
Hadeer Maher Mostafa Mohamed
Assistant Lecturer of Endodontics at Suez University
Faculty of Dental Medicine for Girls