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临床试验/CTRI/2023/02/049512
CTRI/2023/02/049512招募中不适用

A comparative evaluation of effect of osseodensification on bone density around dental implants: A randomized control trial.

Bhujbal Rushikesh Bhau1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年10月2日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
1
主要终点
To compare osteoprotegrin level in periimplant crevicular fluid(PICF) from dental implants placed with osseodensification and conventional technique.

研究概览

简要总结

Introduction

Dental implant is the part of the prosthesisthat interfaces  the bone and supportsthe dental prosthesis. It is a widely used treatment modality.

Primary stability in dental implants is anessential factor for achieving successful osseointegration. Surgical procedureand bone quality are among the most common factors that affect primarystability. It is also crucial to achieve high-insertion torque which isimportant for obtaining primary stability. Maintaining sufficient bone bulk anddensity is essential to achieve necessary bone-to-implant contact for obtaininga biomechanically stable implant. A new concept for osteotomy calledosseodensification (OD) has been at the forefront of changes in surgical sitepreparation in implantology.It is done with specially designedbur that has many lands with a large negative rake angle, which works asnoncutting edges to increase the density of the bone as they expand anosteotomy.

The bone density corresponds to the boneremodelling activity of osteoblast and osteoclast. Local factors like levels ofosteoprotegrin(OPG) has a significant role in it.

OPG is expressed by osteoblast.

The OPG protein is a novel member of TNFfamily.It is a regulator of bone density that act locally and systematically bynegatively regulating osteoclast maturation.

Its expression is regulated by most ofthe factors that induce RANKL expression by osteoblasts. OPG protects the skeleton from excessive bone resorption bybinding to RANKL and preventing it from binding to its receptor, RANK.

 The aim of the present study is to comparatively evaluatethe effect of osseodensification technique on bone mineral density.

RESEARCH HYPOTHESIS:

Null Hypothesis

It will behypothesized that thereis no significant change in bone mineral density and osteoprotegrin arounddental implants placed through conventional drilling protocol with osseodensificationand conventional drilling protocol.

Objective :

1)To compare osteoprotegrinlevel  in Periimplant crevicularfluid(PICF) from dental implants placed with osseodensification andconventional technique.

  1. To compare bone mineral densityaround implants placed with osseodensification and conventional technique.

  2. To find association betweenosteoprotegrin and bone mineral density.

Thistrial is in accordance with theConsolidated Standards of Reporting Trails(CONSORT) criteria, 2010.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Partial Edentulism in Maxilla.
  • Adequate Oral hygiene.
  • Adequate bone volume for implant placement.

排除标准

  • Systemic Diseases.
  • Habit of smoking and chewing tobacco.
  • Bruxism 4)Bone diseases.

结局指标

主要结局

To compare osteoprotegrin level in periimplant crevicular fluid(PICF) from dental implants placed with osseodensification and conventional technique.

时间窗: 1)2 weeks | 2)12 weeks

次要结局

  • To compare bone mineral density around dental implants placed with osseodensification and conventional technique.(1)Pre-operative(Baseline))
  • To find association between osteoprotegrin and bone mineral density.(1)2 weeks)

研究者

发起方
Bhujbal Rushikesh Bhau
申办方类型
Other [self]

研究点 (1)

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