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临床试验/NCT06599112
NCT06599112招募中不适用

Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement Techniques: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Implant stability.

研究概览

简要总结

This study aims to compare the implant stability values following implant placement via Osteotomes and via Osseodensification using Densah Burs versus implant placement using conventional drilling technique in patients with upper posterior partially edentulous ridges as well as evaluating the crestal bone loss around temporary restorations following the three compared drilling techniques.

详细描述

  • Patients with partially edentulous ridges seeking restoration of their missing teeth, with enough measurements for implant placement will be recruited from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University to participate in this study and will be randomized to be either undergoing conventional drilling according to the manufacturer's instructions (control group) or either one of the two intervention groups; Intervention group (A) where implant placement will be done using the Osseodensification technique by the Densah burs or Intervention group (B) where the implant placement will be done using the Osteotomes.
  • Neobiotech IS III active implants will be used in this study, they have an osseoconductive SLA-coated surface, a tapered design with a crestal macrothread design (0.8 pitch), a self compactable apex as well as deep thread to maximize implant stability. The implant has a platform switching feature and a conical/hex design.
  • A temporary PMMA crown after 3 months from implant placement and will be kept for follow up for a year then definitive final restoration will be made.

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

  • Participants and investigator couldn't be blinded.
  • Outcome assessor and biostatistician will be blinded.

入排标准

年龄范围
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an age range of 25-70 years
  • Patients with systemic health
  • Patient with missing teeth in the upper posterior area
  • Patients with D3 or D4 type of alveolar bone
  • Healed bony sites with sufficient dimension for implant placement
  • Vertical height (≥ 10 mm)
  • Bucco-lingual dimension (≥ 5.5 mm)
  • Mesio-distal width (≥6.5 mm)
  • Patients with periodontal health (PD < 4mm, BOP < 10%)
  • Inter-arch space of 7.5 to allow implant restoration
  • Good oral hygiene
  • Cooperative patients who accepted the trial follow up period and sign the informed consent

排除标准

  • Pregnant females
  • Patients with habits that may compromise the longevity and affect the result of the implant as alcoholism or parafunctional habits
  • History of radiotherapy or use of bisphosphonates

结局指标

主要结局

Implant stability.

时间窗: Will take place at same day,1,2,3,4,6,8 ,12and 16 weeks postoperatively.

ISQ units. (Implant Stability Quotient)

次要结局

  • Crestal bone loss(Will be evaluated to determine the initial crestal bone level at day of the surgery as well at 12 and 48 weeks postoperatively.)

研究者

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

Nadine Yehia Mohamed Mohamed Fayed

Principal Investigator

Cairo University

研究点 (1)

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