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临床试验/NCT05895903
NCT05895903已完成不适用

Evaluation of Dental Implant Stability in Narrow Alveolar Ridges Utilizing Osseodensification Technique Versus Screw Expansion: A Comparative Clinical Study

University of Baghdad1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2021年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Primary stability

研究概览

简要总结

Alveolar ridge expansion is suggested for alveolar crest thicknesses of 3-5 mm. Osseodensification (OD) and screw expansion (SE) techniques have been utilized to expand narrow alveolar ridges (NAR). This study aims to compare the implant stability quotient (ISQ) values of endosteal dental implants (DIs) inserted into NAR via osseodensification versus manual screw expansion.

详细描述

This study aimed to evaluate implant primary stability using Densah bur in comparison with screw expander in narrow alveolar ridge.

The patient is instructed to gargle with 0.2% chlorhexidine mouthwash, scrubbing the perioral area with 10% povidone iodine and draping the patient head with disposable drapes.

The surgery will be performed under local anesthesia using lidocaine hydrochloride 2% with adrenaline 1:8000, the surgical procedure started with flap reflection. A mucoperiosteal elevator was used to reflect the buccal and palatal flaps that were enough to expose the crestal part of alveolar ridge with clear visibility and accessibility.

For Expander group:

The screw expanders will be use to expand the osteotomy site. The diameters will be use 2.3mm ,2.6 mm, 3 mm, 3.4 mm, 3.8 mm in a successive manner. Each expander will be screw until 10 mm of depth is reached as mark on the expander. Each expanders is gently screwed half turn at a time; to allow slow and gradual expansion of the bone . When necessary, the kit ratchet is used to reach the full depth required. After the use of the final expander, an implant of appropriate size will place.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

A randomized allocation sequence created using GraphPad Prism 9 software divided the patients in two groups.

入排标准

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

入选标准

  • 未提供

排除标准

  • Uncontrolled medically compromised patients.
  • Heavy smokers (> 20 cigarettes per day)
  • Patient with parafunctional habits.
  • Local infection at implant site.

结局指标

主要结局

Primary stability

时间窗: At the time of surgery

After implant insertion, the multipeg was screwed into the implant fixture, and stability measurement was conducted with the Osstell® ISQ device in two directions (buccolingual and mesiodistal). The mean of these two measurements was recorded as an ISQ value.

Alveolar ridge thickness

时间窗: At the time of surgery

Alveolar bone thickness was measured after osteotomy site preparation.

次要结局

  • secondary stability(6 months)

研究者

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

Nawfal Hasan Abbas Tofan

principal investigator

University of Baghdad

研究点 (1)

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