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临床试验/NCT06639893
NCT06639893已完成早期 1 期

Crestal Bone Loss in Mandibular Telescopic Implant Retained Overdenture with Milled Titanium, Milled Poly-ether Ketone Ketones and 3D Printed Chrome Cobalt Secondary Copings

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Crestal bone loss.

研究概览

简要总结

The objective of this clinical trial is to evaluate crestal bone loss every three months at time of overdenture insertion, 3, 6, 9, 12 months from overdenture use. Also, to evaluate prosthesis satisfaction.

All participants will receive conventional complete dentures, followed by two intraforaminal implants. After healing time, fabrication of secondary copings in all cases according to randomized groups for final overdenture insertion.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sufficient remaining bone in height, width and thickness in the interforaminal area to allow installation of at least 3.3 mm diameter and 8 mm length implants.
  • Adequate amount of interarch space of at least 12mm.
  • Age range from 55 to 75 years old age.

排除标准

  • Systemic and metabolic diseases that may affect osseointegration.
  • Patients receiving bisphosphonates therapy.
  • Patients under radiotherapy or chemotherapy.

结局指标

主要结局

Crestal bone loss.

时间窗: one year

The aim of this study was to evaluate crestal peri implant bone loss in mandibular telescopic implant retained overdenture with milled titanium, milled poly-ether ketone ketones and 3D printed chrome cobalt secondary copings. Crestal bone loss evaluated every three months using standardized digital periapical radiograph at time of overdenture insertion, 3, 6, 9, and after 12 months from overdenture use.

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

Moustafa mohamed el maghraby

Assistant lecturer of prosthodontics

Minia University

研究点 (1)

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