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临床试验/NCT07077915
NCT07077915Enrolling By Invitation不适用

Osseodensification vs Conventional Drilling for Immediate Dental Implant Placement: A Randomized Controlled Clinical and Radiographic Study

Mohamad Ali Itani1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
24
试验地点
1
主要终点
Interradicular bone width

研究概览

简要总结

Aim of the study is to analyze and compare the characteristic differences occurring in the surrounding bone in an immediate implant placed by osseodensification to immediate implants placed with the conventional technique

详细描述

A bifurcation inter-radicular bone of 2 mm or more in a none restorable lower molar will be needed in order to successfully be able to drill the bone with conventional or Osseo densification burs, followed by placing the implant at this site. A xenograft bone material will be used to fill the extraction socket and a customized temporary abutment using flowable composite and a silicone mold will be fabricated and placed over it after polishing it.

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
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient age 25 to 45 years old
  • •Systemically and periodontally healthy individuals.
  • •Non-smokers or light smokers (Less than 5 cigarettes a day) (Schane 2010).
  • •Good oral hygiene.
  • •Healthy remaining dentition.
  • •Adequate quality and quantity of bone
  • •Interradicular septum ≥ 2 mm (Bleyan, 2022).
  • •Mandibular non-restorable molars.
  • •Type A or B socket (Smith and Tarnow, 2013).

排除标准

  • •Acute inflammation or infection in the implant region.
  • •Patients with mental disorders who could not cooperate with treatment or communicate normally.
  • •Patients who have severe systemic disorders (Uncontrolled Diabetes, Uncontrolled Hypertension, End stage kidney or liver diseases and Severe Heart diseases) .
  • •Poor oral hygiene.
  • •Active periodontal disease.
  • •Uncooperative patients, not willing to adhere to post-surgical instructions and follow up visits.

研究组 & 干预措施

Osseodensification burs

Experimental

干预措施: Osseodensification burs (Other)

Conventional Burs

Active Comparator

干预措施: Conventional burs (Other)

结局指标

主要结局

Interradicular bone width

时间窗: Intraoperative (at time of surgery)

The width of the interradicular bone in the interradicular septum will be measured immediately before and after drilling is performed during surgery. Measurements will be taken using a UNC-15 periodontal probe and recorded in millimeters (mm).

Dental implant stability

时间窗: up to 4 months after dental implant placement

Implant stability will be assessed using the Osstell device, which uses resonance frequency analysis to calculate an Implant Stability Quotient (ISQ). ISQ values range from 1 to 100, with higher values indicating greater implant stability.

次要结局

  • Marginal Bone Level(up to 7 months after the implantation)
  • Bone density(up to 7 months after dental implant placement)

研究者

发起方
Mohamad Ali Itani
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamad Ali Itani

Master of Science candidate in Periodontics

Beirut Arab University

研究点 (1)

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