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临床试验/NCT02617212
NCT02617212已完成不适用

Impact of Implant Abutment Dis-/Reconnection on Peri-Implant Marginal Bone Loss - Randomized Clinical Trial.

Fortaleza University2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年11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
26
试验地点
2
主要终点
Peri-implant marginal bone level change.

研究概览

简要总结

The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.

详细描述

The proposed study is a randomized clinical trial in which the participants will be allocated into one of the two arms according to the proposed intervention: experimental group, in which the abutments will be permanently connected immediately at the implant placement procedure; and control group (active comparator) with conventional treatment, where the abutments will be disconnected and reconnected three times.

Considering the inclusion and exclusion criteria related to oral and systemic health, a sample of participants will be selected among those partially edentulous patients who seek for dental implants treatment at the Fortaleza University School of Dentistry.

The sample size has been calculated based on the standard deviation of 0.17 mm, significance level of 5% and 80% statistical test power. To detect a clinically significant difference of 0.2 mm, each group should be composed of 11 participants. Therefore, considering a 10% margin for possible dropouts or missing data, the study will include 24 participants divided into two groups. Each participant will receive one or two implants according to his/her needs, so the study may include more than 24 implants.

A single surgeon will perform the implant surgical procedure in order to reduce variations inherent to clinical experience. After local anesthesia and incision on the top of the alveolar ridge, the bone will be exposed by the mucoperiosteal flap elevation. The mucosal thickness will be measured at implant sites, before the lingual/palatal flap elevation, with a periodontal probe.

The drilling sequence will be done according to manufacturer's recommendations, under saline solution irrigation, intermittent movements and speed up to 1200rpm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Partially edentulous patients requiring dental implant treatment for one or two dental units;
  • Occlusal stability and regular occlusal plane;
  • Enough space for implant and prosthesis;
  • Good periodontal health
  • Keratinized mucosa width > 4mm;
  • Implant primary stability > 65 ISQ and insertion torque > 20Ncm;

排除标准

  • Diabetes mellitus;
  • Treatment with bisphosphonates;
  • Head and neck irradiation;
  • General contraindications to oral surgery;
  • Pregnancy;
  • Bone graft;
  • Smoking habits.

结局指标

主要结局

Peri-implant marginal bone level change.

时间窗: 2, 6, 12 and 24 months after implant surgery.

To estimate the gingival margin stability and the long-term success of implant-supported restorations, the peri-implant marginal bone level will be assessed as primary outcome through intraoral radiographs, in a perspective of bone maintenance, bone loss or bone gain.

次要结局

  • Gingival level change.(6, 12 and 24 months after implant surgery.)
  • Implant stability change.(3 and 6 months after implant surgery.)
  • Peri-implant probing depth change.(12 and 24 months after implant surgery.)
  • Bleeding on probing change.(12 and 24 months after implant surgery.)

研究者

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

Luciano de Freitas Guimarães Praça

MS

Fortaleza University

研究点 (2)

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