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临床试验/CTRI/2023/11/059974
CTRI/2023/11/059974尚未招募不适用

Comparative Evaluation Of Primary And Secondary Stability Of Implants Placed Through Osseodensification Versus Standard Drilling Technique - A Randomized Controlled Trial

Shraddha Shilpi1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年11月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
2. Secondary Implant Stability

研究概览

简要总结

Standard Drilling Technique results in excavation of bone to create room for implant fixation, that results in reduced Insertion Torque Value and Implant Stability Quotient leading to poor primary stability and potential decrease in osseointegration. In contrast, Osseodensification doesn’t excavate bone tissue, instead it compacts and autografts bone tissue in outward expanding direction in the osteotomy wall along the entire depth of the hole. Ergo, it increases bone density surrounding the preparation of implant site resulting in good implant stability. Use of specialized Densah Drills for Osseodensification in non-cutting direction with continuous slow irrigation produces controlled plastic deformation in bone resulting in its expansion in areas of narrow ridges.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •1.Physically, Mentally, and Systemically healthy patient.
  • •2.Single / multiple missing teeth (anterior/posterior maxilla or posterior mandible).
  • •3.Subjects with good plaque control, showing good compliance, willing to participate in the study.

排除标准

  • •Subjects with systemic illness, osteoporosis, bleeding disorders etc.
  • •Insufficient density or height of residual ridge.
  • •Pregnant and Lactating females.
  • •Subjects with history of smoking or smokeless tobacco.
  • •drug or alcohol abuse.
  • •Occlusal interferences.
  • •Subjects with history of allergy.
  • •Radiotherapy/ Chemotherapy for malignancy.

结局指标

主要结局

2. Secondary Implant Stability

时间窗: 1. Time Point for Primary Implant Stability is- Immediate Post Implant Placement | 2. Time Point for Secondary Implant Stability is- 4 months after Implant Placement

1. Primary Implant Stability

时间窗: 1. Time Point for Primary Implant Stability is- Immediate Post Implant Placement | 2. Time Point for Secondary Implant Stability is- 4 months after Implant Placement

次要结局

  • 1.Bone Density(2.Crestal Bone Level)

研究者

发起方
Shraddha Shilpi
申办方类型
Other [Self Sponsoring]

研究点 (1)

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