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临床试验/NCT06281535
NCT06281535Unknown不适用

Early Versus Conventional Loading for Fully Guided Immediate Implant Placement in Molar Sites (A Randomized Controlled Clinical Study)

Ain Shams University0 个研究点目标入组 24 人开始时间: 2024年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
Implant stability

研究概览

简要总结

Conventional loading protocol following implant placement 3 -6 months is considered the gold standard. However, early loading following 2 months after implant placement decreases the time and had a good survival rate.

详细描述

The conventional loading protocol presented involves healing period of 3 -6 months. A healing period without stress was recommended in the order to present better survival rate. This loading protocol was developed in the time when micro- and macro design of implant surface was machine produced. Early loading of dental implants within 2 months following placement on healed posterior mandible showed 100% survival rate for five years follow up, with uneventful crestal bone loss. The lack of difference between conventional loading 6 months following implant placement and early loading could be explained by the fact that even if the crowns were not put in direct occlusion, patients used them functionally when chewing. The most relevant factor which may explain the positive results obtained in this trial is the high insertion torque at implant placement.

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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients age range from 20-60 years.
  • •Molar tooth to be extracted due to periodontal diseases, peri- apical diseases, Endo-perio diseases, or tooth fracture.
  • •Primary implant stability is above 30 Ncm.

排除标准

  • •History or presence of severe uncontrolled systemic disease.
  • •Heavy smokers (>10 cigarettes per day) or alcohol/drug abusers.
  • •Poor oral hygiene.
  • •Acute periapical infection.

研究组 & 干预措施

Early loading group

Experimental

The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 2 months following implant placement.

干预措施: Implant loading (Device)

Conventional loading group

Active Comparator

The surgical treatment protocol entails atraumatic tooth extraction, fixture insertion and placement of the final restoration 3 months following implant placement.

干预措施: Implant loading (Device)

结局指标

主要结局

Implant stability

时间窗: 2 and 3 months following implant placement

Degree of implant stability will be measured by Osstell device as a scale from 1 to 100

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

Doaa Adel Salah Khattab

Associate Professor

Ain Shams University

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