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临床试验/NCT05390242
NCT05390242Unknown不适用

Peri-implant Marginal Bone Loss and Implant Failure in Patients With Smoking Habit: a Case Control Study

University of Barcelona1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年2月21日最近更新:
适应症

试验速览

阶段
不适用
入组人数
44
试验地点
1
主要终点
Marginal bone loss measured on Periapical Radiography

研究概览

简要总结

The impact of smoking on dental implant failure has been a constant topic of discussion for the past decade and the current literature confronts the inconclusive evidence of tobacco for a marginal bone loss risk factor. The aim of the present investigation is to determine the association between tobacco and marginal bone loss or implant failure in a sample of patients who had received implant-supported restorative therapy in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

Considering that peri-implant marginal bone is essential for dental implant success, in this study we would like to establish the relationship between marginal bone loss around implants and smoking, in our own population study, in order to improve the prognosis of implant success in smoking patients.

On the other hand, knowing the negative effect tobacco has on marginal bone loss in dental implants, we will be able to better predict peri-implant bone loss and reveal the probability of implant failure in short and long-term in smokers. By informing the patient correctly, we can raise awareness and create an additional reason for them to stop smoking, or at least reduce the number of cigarettes they smoke per day.

详细描述

The present study was designed as a retrospective case control study in a sample of patients with implant-supported restorative therapy conducted at the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge). It is designed following the principles outlined in the Declaration of Helsinki (revised, amended, and clarified in 2013). All of the patients are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions. Patients provided with implant-supported restorative therapy were selected from the DHUB database. The sample is divided in two groups: smoking and non-smoking patients. An initial questionnaire is being conducted to obtain information regarding smoking habits. Candidates undergo an oral examination, radiographic study (Orthopantomography and Implant periapical radiograph) and implant probing to determine their peri-implant status.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a Smoking Habit
  • Patients 20 - 80 years old
  • Patients rehabilitated at DHUB
  • Patients with a radiographic record at the time of implant loading
  • Patients rehabilitated with one or more dental implants

排除标准

  • Patients with untreated periodontal disease
  • Patients with uncontrolled systemic pathology
  • Pregnant women or in lactation
  • Patients treated with antiresorptive drugs
  • Patients without radiographic records

结局指标

主要结局

Marginal bone loss measured on Periapical Radiography

时间窗: 60 minutes

Marginal bone loss (MBL) around dental implants

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lina Dumanova

Principal Investigator

University of Barcelona

研究点 (1)

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