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临床试验/NCT05739461
NCT05739461已完成不适用

The Effect of Triangular Cross-section Neck Design on Crestal Bone Stability in the Anterior Mandible: A Retrospective Study With a 5-year Follow-up

Kocaeli University1 个研究点 分布在 1 个国家实际入组 17 人开始时间: 2022年9月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
comparison of crestal bone loss

研究概览

简要总结

The objective of this retrospective study with 5-year follow-up was to compare crestal bone loss (CBL) and buccal bone thickness (BBT) around triangular cross-section neck (TN) to round neck (RN) implants retaining mandibular overdentures, using cone-beam computed tomography

详细描述

CBL is a multifactorial entity including factors related to patients, surgical technique, prosthetic interventions, and implant design. Thus, new developments in implant micro- and macro-features, such as modifications of surface characteristics and chemistry, type of abutment connection, thread design, and neck design have been introduced over time parallel to recent advances in implantology not only for reducing CBL, but also for preserving buccal bone dimensions around implant. Furthermore, implant neck properties have been considered as a determinant factor involved in maintenance of crestal bone around implant in various trials. Nevertheless, there is no consensus with respect to the design of implant neck for reducing CBL.

The most common implant neck design is the circular one; recently, however, a newly designed implant with a triangular neck (TN) portion was introduced, which has reduction in the neck portion on three sides. This neck design provides compression-free area to alveolar crest during implant insertion to minimize CBL. In addition, TN design also would enhance the BBT by increasing the space between the flat part of the triangle and the buccal bone cortex. Based our previous study with one-year follow-up, despite the implants with novel neck design showed a better crestal bone preservation compared to conventional neck design, long-term clinical trials determining the effect of TN are missing for validating the success of this new design. Unfortunately, the data derived from only very few short-term comparative clinical trials to date do not provide an answer on benefits of TN design over the CN implants regarding preserving crestal bone level.

Thus, this retrospective study with up-to-x-month follow-up aimed to compare CBL and BBT around implants with TN and RN retaining mandibular overdentures. The null hypothesis was that there was a difference in CBL and BBT between two implant designs in the long-term follow-up.

研究设计

研究类型
观察性
观察模型
其他
时间视角
回顾性

入排标准

年龄范围
59 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • Patients over 18 years old.
  • Mandibular total edentulism.
  • Presence of sufficient residual bone width (>5 mm) and length (>10 mm).
  • Sufficient keratinized gingiva crestally (≥4 mm).
  • Sufficient interarch space.
  • Sufficient vestibular depth.
  • Patients had their teeth extracted at least three months before surgery.

排除标准

  • Patients with any systemic disease or condition that can/could compromise osteointegration (cancer, diabetes mellitus, osteopo- rosis, and cardiovascular diseases).
  • Presence of any drug use that could affect bone metabolism.
  • Presence of immunocompromising conditions.
  • Presence of any pathology in the mandible.
  • Allergy to any drugs used in the postoperative period.
  • Patients who are smokers.

结局指标

主要结局

comparison of crestal bone loss

时间窗: February 2023

comparison of buccal bone thickness

时间窗: February 2023

次要结局

未报告次要终点

研究者

申办方类型
其他
责任方
主要研究者
主要研究者

Berkay Tokuç

Assist. Prof.

Kocaeli University

研究点 (1)

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标识符

NCT 编号
NCT05739461
其他研究编号
2022/158

日期

首次提交
(3年前)
首次发布
(3年前)
主要完成日期
(3年前)
研究完成日期
(3年前)
最近核实
最近更新
(3年前)

监管与共享

FDA 监管药物
否
个体参与者数据共享计划
UNDECIDED
是否有结果
否

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