Bacterial Microbiota and Its Relation to Antimicrobial Resistance Genes in Implant-supported PEEK and Titanium Provisional Abutments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Changes in the Number of Operational Taxonomic Units (OTUS)
研究概览
简要总结
The aim of this study is to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK implant-supported provisional abutments compared to titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
详细描述
The use of provisional abutments is mandatory during the restorative phase of any implant based oral rehabilitation. The introduction of poly-ether-ether-ketone (PEEK) for the manufacturing of provisional abutments as an alternative to conventional titanium abutments has opened the restorative spectra, offering the clinician and the patient better aesthetics and adhesive outcomes than its predecessor. However, there is to date no clarity on the impact of PEEK on the bacterial growth and the specificity of the microbiota on the abutment surface. Therefore, the present study aims to determine the relative abundances of the different bacterial phyla and families in the microbiota present on the surface of PEEK and titanium implant-supported provisional abutments, as well as the effect of both materials on the presence of antibiotics resistance genes.
Study Hypotheses:
- H1: The characteristics of the bacterial microbiota present at the connection area of implant-supported provisional abutments are dependent upon the abutment material.
- H2: An increased presence of antibiotic resistance genes is found in the bacterial microbiota on titanium provisional abutments when compared to that found on PEEK abutments.
The study uses a metagenomic approach based on the characterization of the bacterial communities, as well as on the sequencing of the 16S gene, and on the other hand, on the sequencing of the high-throughput (HTS) of the whole genome, for variations of the antibiotic resistance genes.
Sample retrieval will be conducted prior to implant placement, at the adjacent teeth gingival sulcus (t0), and two months after provisional abutment (and crown) connection (t1), from the retrieved abutments. Patient allocation in the "PEEK" or "Titanium" groups will be randomized. Intra- and interpatient comparisons will be conducted. Statistical analyses include two-way ANOVA and Tukey's post-hoc test, at p<0.05.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be not aware of the type of provisional abutment used in their treatment. Retrieved samples will be codified in order to mask them for the metagenomic analysis.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I patients
- •Indication of implant treatment to replace an upper or lower premolar
- •Presence of natural teeth adjacent to the implant region
- •Gingival biotype in the posterior region of 3 to 4 mm
排除标准
- •Immunosuppressed patients
- •Tabacco, alcohol or drug addictions
- •History of periodontal disease
- •Need of bone grafting in the implant region
结局指标
主要结局
Changes in the Number of Operational Taxonomic Units (OTUS)
时间窗: Baseline (prior to abutment insertion) and two months after abutment insertion.
Changes in the Number of Operational Taxonomic Units (OTUS) observed after the two months evaluation period will be assessed using UniFrac metrics. The weighted UniFrac distances will be used to perform a principal coordinate analysis (PCO).
Changes in Antibacterial Resistance Genes (ARG)
时间窗: Baseline (prior to abutment insertion) and two months after abutment insertion.
Changes in the ARG of the microbiota will be determined using the whole genome sequencing using the MiSeq Illumina method.
次要结局
- Changes in the number of bacterial species(Baseline (prior to abutment insertion) and two months after abutment insertion.)
研究者
Michael Wendler Ernst
Assistant Professor at the Department of Restorative Dentistry, Faculty of Dentistry
University of Concepcion, Chile