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临床试验/NCT02123420
NCT02123420
已完成
不适用

Platform Switching vs Regular Platform Implants. One Year Results From a RCT

Università degli Studi di Sassari0 个研究点目标入组 18 人2011年11月
适应症Missing Teeth

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Missing Teeth
发起方
Università degli Studi di Sassari
入组人数
18
主要终点
Implant Survival
状态
已完成
最后更新
12年前

概览

简要总结

The present study tested the hypothesis that Platform Switching (PS) and Regular Platform (RP) implants would have different outcomes in the bilateral single tooth replacements against the alternative hypothesis of no difference.

详细描述

This study was designed as a randomised, controlled, split-mouth trial. Eighteen patients, with bilaterally missing single bicuspid or molar had one of the sites to be restored randomly assigned to be treated according to the platform-switching concept with (PS group), or with matching implant-abutment diameters, (RP group). A total of 36 implants, (18 Nobel Replace Tapered Groovy PS, 18 Nobel Replace Tapered Groovy), were bilaterally installed. All the implants were inserted with an insertion torque between 35 and 45 Ncm, in healed healthy bone and the healing abutment was connected at the same time. Both implants were delayed loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 2 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, soft tissue parameters (PPD and BOP). Clinical data were collected at baseline 6 and 12 months. Statistical analyses were conducted using computational program SAS (version 9.2), with 1-away ANOVA and F-test. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation with 95% confidence intervals.

注册库
clinicaltrials.gov
开始日期
2011年11月
结束日期
2013年2月
最后更新
12年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Università degli Studi di Sassari
责任方
Principal Investigator
主要研究者

Silvio Mario Meloni

DDS, Phd, MS

Università degli Studi di Sassari

入排标准

入选标准

  • need for single bilateral fixed implant-supported prosthesis in molar area
  • stable interocclusal contacts
  • ≥18 years of age
  • provided written informed consent
  • residual bone height ≥10 mm
  • residual bone thickness ≥6 mm with at least 5 mm of keratinised gingiva crestally

排除标准

  • general contraindications to implant surgery
  • lack of occluding dentition in the area intended for immediate loading
  • periodontitis
  • immunosuppression
  • previous history of irradiation of the head and neck area
  • uncontrolled diabetes
  • heavy smoker (\>10 cigarettes/day)
  • poor oral hygiene
  • current or past treatment with bisphosphonates
  • substance abuse

结局指标

主要结局

Implant Survival

时间窗: Up to 12 months

implant survival: The removal of implants was dictated by instability, progressive marginal bone loss, infection or implant fracture.

次要结局

  • Change in marginal bone levels(Baseline, 12 months)

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