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临床试验/NCT07534826
NCT07534826已完成不适用

Clinical and Radiographic Evaluation of Osseo Densification Technique Individually or Combined With Low Level Laser in Delayed Dental Implant Type IV Bone: Randomized Controlled Clinical Trial

Faculty of Dental Medicine for Girls1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2023年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
immediate primary implant stability

研究概览

简要总结

A comparative clinical study on 16 patients with Type IV bone, divided into two groups (n=8): implants placed using Densah burs only versus Densah burs combined with laser bio stimulation, to evaluate implant stability and healing.

详细描述

This study was designed as a comparative clinical trial involving two groups of patients receiving dental implants. A total of 16 patients are included, divided equally into two groups (n=8 each).

  • Group 1: Implant placement using Densah burs only.
  • Group 2: Implant placement using Densah burs combined with laser bio stimulation. Both groups were selected with Type IV bone

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)

盲法说明

outcome assessor and statistical analysis helper

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Missing premolar and molar maxillary area with type IV bone density, (based on CBCT and number of Hounsfield units (HU).
  • Patients age should be in the range from 30 up to 60 years old.
  • Free from any systemic conditions and no previous drug affect bone metabolism.

排除标准

  • Pregnant women
  • Patients in variation in anatomical landmarks
  • Patients with psychological problems
  • Patients with bad oral hygiene
  • Patients with parafunction habits.

研究组 & 干预措施

Implant placement using Densah burs only

Active Comparator

all patient's surgeries to receive dental implants were placed using only Densah burs, all patients were selected with type IV Bone. Device used was Densah kit system

干预措施: implant placement using Densah burs (Procedure)

Implant placement using Densah burs combined with Laser biostimulation

Experimental

Surgeries for Implant placement using Densah burs combined with Laser biostimulation Using Densah Kit system as a devices and Low level laser biostimulation

干预措施: implantation using Densah burs with Laser biostimulation (Procedure)

结局指标

主要结局

immediate primary implant stability

时间窗: immediately

Immediate primary implant stability was assessed through the measurement of insertion torque. The unit of measurement is (N.cm)

次要结局

  • Implant stability and ossification(6 months follow up)
  • Modified Plaque Index(after 12 months following up.)
  • Probing depth(after 12 months following up.)
  • Modified gingival index(after 12 months following up.)

研究者

发起方
Faculty of Dental Medicine for Girls
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Doaa Mohammad Bhgaat

Assistant Lecturer of oral medicine and periodontology

Faculty of Dental Medicine for Girls

研究点 (1)

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