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临床试验/NCT06488599
NCT06488599Enrolling By Invitation不适用

Marginal Bone Loss Around Mandibular Implant-retaining Overdentures and Implant Supported Fixed Hybrid Prosthesis: A 5-year Follow-up

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2023年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
19
试验地点
1
主要终点
Marginal Bone Loss in mm (MBL)

研究概览

简要总结

Few if any studies have compared marginal bone loss (MBL) around implant-retaining overdentures (2 implants with locators) versus implant supported fixed hybrid prosthesis (over 4 implants) in the mandible.

详细描述

Material and Methods

Patients of the saint Joseph university dental clinics, who have already in their records peri-apical radiographs of the implants post loading, will be divided in 2 groups depending on the prosthetic treatment that they have had for 5 years in mouth, and will be recalled for a check-up session during which the investigators will take new peri-apical X-rays by means of the parallel long-cone technique for the implants that are supporting/retaining the prosthesis. A total of minimum 50 implants placed in a minimum of 19 patients will be examined. The mean mesial and distal radiographic MBL and bone to implant contact (BIC) will be recorded by comparing the two X-rays for each implant.

the investigators will also investigate the possibly related factors that may have contributed to this marginal bone loss such as the medical history, smoking habits, oral hygiene, compliance, presence of keratinized tissue and possibility of proper cleaning.

Results: the investigators aim to find a statistically significant difference in the Marginal bone loss around implants assisting these two types of prosthesis and a possible correlation with some risk and modifying factors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients treated with mandibular implant-retaining overdentures (2 implants)
  • Patients treated with mandibular implant-supported fixed hybrid prosthesis (4 implants)
  • Patients having in their records a post-loading peri-apical radiograph for the implants
  • Patients who have had their prosthesis for 5 years in mouth

排除标准

  • Patients treated with mandibular implant-retaining overdentures with more or less than 2 implants
  • Patients treated with mandibular implant-supported fixed hybrid prosthesis with more or less than 4 implants Patients treated with any other prosthetic option on implants Patients who don't have a post-loading peri-apical radiograph in their records

结局指标

主要结局

Marginal Bone Loss in mm (MBL)

时间窗: 5 years

MBL in mm around implants in patients having a removable prosthesis over locators and in patients having a screw retained hybrid prosthesis

次要结局

  • sex(5 years)
  • age(5 years)
  • framework design(5 years)
  • compliance and attendance to recall sessions(5 years)
  • keratinized tissue hight(5 years)
  • health status(5 years)
  • plaque score(5 years)
  • smoking status(5 years)

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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