Microbial assessment & quantification following placement of different sealing materials at the screw abutment connection under loading conditions in dental implants A metagenomic study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ii. Metagenomic study can help us know specific microbial niches which form part of specific materials.
研究概览
简要总结
The leakage of microorganisms and fluids to the inner parts of the implants is considerably increased by load application, which generates micro-movements and interfacial gaps. (Khraisat et al., 2006). Bacterial species harboring the internal surfaces of the implants and components is not surprising, since the size of oral bacterial species ranges in average from 1.1 to 1.5 μm in length and 2 to 6 μm in diameter. Smaller species like spirochetes (diameter of 0.1 to 0.5 μm) may also be found in the oral microbiota. (Jansen et al., 1997).
Micro gaps between implant and abutment are generally less than 10 um. Given access to the microgap, bacteria can easily penetrate even through the tightest implant-abutment fittings. Biofilms and bacterial colonization of dental implants. According to Quirynen et al. (2002), gaps in the implant-abutment interface may act as a trap for bacteria, favoring the development of biofilm with varying composition and impact on periodontal tissues. AA, T forsythia and P gingivalis, many times present in these biofilms, are pathogens intimately related to the development and maintenance of periodontitis and peri-implantitis. Considering the increased use of dental implants and recognizing the impact of bacterial leakage along the implant-abutment interface on the health of peri-implant tissues this study was planned.
ABOUT METAGENOMICS-The next culture-independent game changer
Recently, metagenomics was defined as "the application of modern genomics techniques to the study of communities of microbial organisms directly in their natural environments, bypassing the need for isolation and lab cultivation of individual species".
There is no defined consensus among implantologists’ with regard to what is ideal material when it comes to
sealing the implant abutment connection. More so, very few studies have been undertaken under loading
conditions. Different variation of materials have been taken, some new types (e.g. temporary composite
material) to find the best possible combination. This study was therefore planned to reduce the ambiguity with
regard to this very important clinical parameter under loading conditions. Since microbes comprise the primary
factor with regard to implant failure, determining specific microbial niches is of paramount importance and this
study will help us find specific microbial niches (identification and quantification) which can exist with regard
to different sealing agents placed in implant abutment screw hole. Also, swab will be taken around the implant
fixture before placement of abutment as that will act as the control group. So this study was planned to include
highly specific and advanced technique of metagenomics for all cases of implant placement three months after
loading using different sealing materials in implant abutment screw hole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Immediate implant placement or delayed implant placement in adult population more than 18 years of age for both gender.
- •Edentulism in mandibular molar area.
- •B and B implant system to be used in the study.
- •Abutment type.
- •internal hexagon connection.
- •Screw retained prosthesis with access hole.
排除标准
- •Other implant system.
- •Abutment type other than internal hexagon connection.
- •Cement retained prosthesis.
- •Patient suffering from any uncontrolled systemic condition
- •Patient suffering from active periodontal disease, or if patient has undergone any periodontal treatment in past 06 months.
结局指标
主要结局
ii. Metagenomic study can help us know specific microbial niches which form part of specific materials.
时间窗: Recruitment-one year | Metagenomic analysis- two years
Immediate
时间窗: Recruitment-one year | Metagenomic analysis- two years
i. Material which contains largest quantity of oral microbes can be avoided since it can affect the success rate of implants.
时间窗: Recruitment-one year | Metagenomic analysis- two years
i. Since the success rate of implant is 90% for 10 years and 80% for next 10 years IMPLANT MAINTENANCE is important.
时间窗: Recruitment-one year | Metagenomic analysis- two years
Long term
时间窗: Recruitment-one year | Metagenomic analysis- two years
ii. The present study is clinically relevant as changing material at screw-abutment connection forms an important protocol in follow up.
时间窗: Recruitment-one year | Metagenomic analysis- two years
iii. The best material which supports the least microbiome forms part of long term expected outcomes.
时间窗: Recruitment-one year | Metagenomic analysis- two years
次要结局
- Long term(i. Since the success rate of implant is 90% for 10 years and 80% for next 10 years IMPLANT MAINTENANCE is important.)
