Early Healing of Oral Soft Tissues: a Clinical and Biomolecular Analysis. Part II - Effect of Local Chlorhexidine Administration in Gene Expression and Cellular Behaviour 24-hours After Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Changes from baseline fold regulation wound healing related genes at 24 hours after post-surgical chlorhexidine use.
研究概览
简要总结
The purpose of the present study is to evaluate the influence of the post-surgical chlorhexidine indication in the gene expression profile and cellular behavior in the early wound healing process -24 hours after injury- of the oral soft tissues.
The main hypothesis is that the post-surgical use of chlorhexidine affects the gene expression and the celular behavior in the early wound healing process of the soft oral tissues.
详细描述
The bacterial infection control in the wound healing is a very important aspect to considerer. Local antiseptic administration after the surgical procedures has been used to control the bacterial contamination.
Chlorhexidine (CHX), widely used as antiseptic, especially as post-surgical indication, has a toxic effect both in vivo and in vitro and their influence on wound healing has been studied for a long time. One of the first animal studies, in 1980, concluded that intensive rinsing with high concentrations of chlorhexidine after oral surgical operations, could result in delay and disturbance of wound healing. Another more recent animal study concluded that CHX induces apoptosis or necrosis in the fibroblasts.
Mariotti and Rumpf, in 2016, carried out a studied incubating human gingival fibroblasts in CHX. The results have been suggested that chlorhexidine could induce a dose dependent reduction in cellular proliferation and that concentrations of chlorhexidine that have little effect on cellular proliferation can significantly reduce both collagen and non-collagen protein production of human gingival fibroblasts in vitro. Hence, the introduction of commercially available concentrations (0.12%) or diluted commercial concentrations (as low as 0.00009%) of chlorhexidine to surgical sites for short periods of time prior to wound closure can conceivably have serious toxic effects on gingival fibroblasts and may negatively affect wound healing.
All the previous mentioned studies permit understand that the CHX is not harmless to the oral tissues. However, its effect is not entirely clear and should be evaluated in depth taking into account that it is one of the most indicated antiseptics after surgery. Currently, there are no studies that evaluate if the post-surgical use of CHX affect the gene expression in the early wound healing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients that required periodontal surgery;
- •patients age between 30-60 years;
- •patients with full mouth plaque score and full mouth bleeding score < 15%;
- •patients with a good general healthy status;
- •patients without any medicaments or drug consumption that can affect the healing process;
- •non-smoking patients.
排除标准
- •patients in pregnancy;
- •patients in lactation period;
- •patients with consumption of antibiotics or anti-inflammatory drugs in the previous six months;
- •patients with systemic diseases.
结局指标
主要结局
Changes from baseline fold regulation wound healing related genes at 24 hours after post-surgical chlorhexidine use.
时间窗: 24 hours after surgery (T24)
Total RNA from biopsies or cell cultures was extracted using TRIzol reagent Quantitative real-time PCR (qRT-PCR) cDNA was generated and cDNA obtained were used for amplification of wound healing related genes using the appropriate TaqMan gene expression assay kits.
次要结局
- Clinical evaluation of early wound healing(24 hours after surgery (T24))
研究者
Andrea Pilloni MD DDS MS
Chairman Section of Periodontics Director of Master Program in Periodontics
University of Roma La Sapienza