Establishing a New Protocol for Early Mucositis and Peri-implantitis Treatment Using an Air-polishing Device
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from baseline peri-implant inflammation at 6 months
研究概览
简要总结
Considering the frequent occurence of peri-implantitis and mucositis, a multiple of treatment alternatives have been proposed including non-surgical and surgical procedures. However, it seems that the most effective treatment remains prevention of these diseases.
The aim of this study is to emphasize on mucositis and peri-implantitis prevention using an air abrasion device the Air-Flow Master Piezon® with erythritol and chlorhexidine powder in order to eliminate and / or disorganize the biofilm responsible for peri-implant mucosa inflammation.
详细描述
Peri-implant infections (mucositis and peri-implantitis) depict an increasing focus in dental practice and implantology. mean prevalence of mucositis is of 43% and periimplantitis of 22%. Consequences for the implant without successful treatment range from local reversible inflammation (mucositis) to implant loss (periimplantitis). These lead to functional, social and esthetic prejudices for patients. The main factor for establishment of peri-implant infections is the formation and maturation of the bacterial biofilm. Peri-implantitis and mucositis treatment require the removal of the bacterial biofilm and the disinfection of the implant surface. Because of special surface conditions and structures, it is more difficult to remove bacterial biofilms from implant surfaces than teeth. the key to controlling the inflammation due to the bacterial biofilm is to prevent its installation and progression. The procedure tested in this study is an air abrasion device, the Air-Flow Master Piezon® with erythritol and chlorhexidine powders on implants presenting clinical and radiographic signs of mucositis and peri-implantitis along with renewal of local oral hygiene instructions in order to reduce the inflammation locally by disorganizing and eliminating the biofilm. Follow-up of the patients will be held every 2 months for 6 months by scoring the bleeding on probing, the plaque index and measuring clinical attachment level in order to compare it with the initial measure. At 6 month an X-ray will also enable to compare bone level and mineralization. This initial study will help establish a standardized protocol for peri-implant infection management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients,
- •possessing one or more implants prosthetically engaged with local peri-implant mucosa inflammation assessed by bleeding on probing
- •affiliated with a social security scheme
排除标准
- •patients with implant mobility or implants associated with vestibular cellulitis
- •not available patients for the follow-up visits
- •patients with known allergy to erythritol and/or Chlorhexidine powder
- •patients with chronic bronchitis
- •patients with asthma
- •patients with endocarditis
- •patients with contagious disease
- •patients with immunodeficiency
- •patients under radiotherapy and/or chemotherapy and/or antibiotics
- •not mastery of plaque control on the part of the patient (after education)
- •subjects under legal protection
- •pregnant or breastfeeding women
结局指标
主要结局
Change from baseline peri-implant inflammation at 6 months
时间窗: 6 months
bleeding on probing (binary criteria : yes/no)
Change from baseline peri-implant inflammation at 4 months
时间窗: 4 months
bleeding on probing (binary criteria : yes/no)
Change from baseline peri-implant inflammation at 2 months
时间窗: 2 months
bleeding on probing (binary criteria : yes/no)
次要结局
- stability of the bone level(6 months)
- clinical attachment gain(6 months)
- Quality of life with Oral Health Assessment Tool (OHAT)(6 months)
- Quality of life with the Geriatric Oral Health Assessment Index (GOHAI)(6 months)
