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临床试验/NCT02840773
NCT02840773已完成不适用

Impact of Implant-abutment Connection on Osteoimmunological Parameters in Short Implants: a Randomised Controlled Clinical Trial

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2010年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Peri-implanter sulcus fluid levels of RANKL

研究概览

简要总结

The aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.

详细描述

The peri-implant crevicular fluid (PICF) contains several inflammatory mediators; the level of these mediators can provide information on the inflammatory state of the tissue, including the activation of mechanisms of bone destruction. In this context, soluble receptor activator of nuclear factor кB ligand (sRANKL) and osteoprotegerin (OPG) have been suggested as molecular determinants of bone resorption. However, currently, there are only limited studies on the molecular responses of healthy peri-implant tissues following placement of implants on function. The null hypothesis of the present study was that there are no significant differences in the levels of sRANKL and OPG in PICF or in the respective levels of six bacterial species or total bacteria levels in submucosal biofilm samples taken from TIF- and TIS-type implants. Therefore, the aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.Thirty short implants were randomly placed in posterior maxillary edentulous sites using a split-mouth design in 15 periodontally healthy subjects. Tapered interference fit (TIF) and taper integrated screwed-in (TIS) types of implant-abutment connections were selected for investigation. PICF and submucosal biofilm samples were collected one month after surgery and repeated 12 months after prosthetic loading. Clinical parameters, including probing depth, dichotomous presence of bleeding on probing, and plaque index, were recorded and digital periapical radiographs were taken at each time point. sRANKL and OPG levels in PICF were analyzed using an enzyme-linked immunosorbent assay. Total bacterial levels, as well as levels of Fusobacterium nucleatum, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, and Streptococcus oralis, were analyzed in corresponding submucosal biofilm samples using quantitative real-time polymerase chain reaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sufficient bone height for a 6 mm implant and sufficient bone width for a minimum 5.5 mm implant without any augmentation techniques
  • no history of periodontitis.

排除标准

  • Patients with any systemic diseases
  • Smokers were excluded

结局指标

主要结局

Peri-implanter sulcus fluid levels of RANKL

时间窗: 12 month

Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.

Peri-implanter sulcus fluid levels of OPG

时间窗: 12 month

Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.

次要结局

  • Probing depth(12 month)
  • Bleeding on probing(12 month)
  • Crestal bone loss(Between baseline and 1 year after prosthetic loading)
  • Plaque index(12 month)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Veli Özgen Öztürk

PhD, DDS

Aydin Adnan Menderes University

研究点 (2)

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