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临床试验/CTRI/2024/09/073785
CTRI/2024/09/073785尚未招募不适用

A COMPARATIVE EVALUATION OF THE EFFECTS OF PROGRESSIVE AND CONVENTIONAL LOADING PROTOCOL ON DENTAL IMPLANTS PLACED USING OSSEODENSIFICATION AND CONVENTIONAL DRILLING PROTOCOL- AN IN-VIVO STUDY

Krishna Vishwa Vidhyapeet1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年10月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Primary stability at implant placement, after 6 months and after 12 months

研究概览

简要总结

Dental implants, in today’s world are considered one of the best alternatives for replacement of missing teeth, showing better results in esthetics and function. The success rate of dental implants depends largely on the quality of bone present, and the ridge, which may come as a challenge to the implantologist. Implants placed in poor quality bone are often related to compromised stability and poor Osseo- integration.

 The Osseodensification technique, could increase primary stability of dental implant in poor quality bone. This procedure is characterized by low plastic deformation of bone that is created by rolling and sliding contact using a densifying bur (Densahâ„¢ burs) that is fluted such that OD does not excavate bone but simultaneously compact and autografts the particulate bone in an outward direction to create the osteotomy, thereby preserving vital bone tissue and densifying the bone at the site.

 Bone is known to form under mechanical stresses. Implants loaded using the progressive loading technique, in which a temporary prosthesis is placed within 48 hours at infra-occlusion and is then adjusted at regular intervals to increase the height of the prosthesis until it is eventually brought into occlusion, has in this regard shown less peri implant bone loss and better implant success rate.

 Resonance frequency analysis (RFA) is a non-invasive technique that gives a clinical measure of stability and presumed osseo-integraion of the placed implant.

 The experimental design consists of

Group A – Implants placed using Osseodensification technique

·          Sub group 1- Implants loaded using progressive loading protocol

·         Sub group 2- Implants loaded using conventional loading protocol

Group B – Implants placed using conventional implant placement technique

·         Sub group 3- Implants loaded using progressive loading protocol

·         Sub group 4- Implants loaded using conventional loading protocol

All the groups will be subjected to Resonance Frequency Analysis(RFA) to determine the implant stability quotient (ISQ)at

1.      Implant placement

2.      After 6 months

3.      After 12 months

The crestal bone loss of the groups will be radiographically determined at

1.      Implant placement

2.      After 6 months

3.      After 12 months

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Two or more missing teeth , adequate bone height, width and optimal bone density, patients physical status,ASA Classes I & II.

排除标准

  • Undermined systemic disorders and immunosuppersed patients and patients with uncontrollled hypertension and diabetis.
  • patients smoking more than 5 cigarettes per day and who have history of alcoholism/drug abuse during last 5 years patients with history of chemotherapy or radiation for last 12 months poor oral hygiene and severe uncontrolled periodontitis.

结局指标

主要结局

Primary stability at implant placement, after 6 months and after 12 months

时间窗: Primary stability at implant placement, after 6 months and after 12 months

次要结局

  • To determine & compare the primary implant stability quotient (ISQ) values of dental implants placed with Osseodensification & conventional protocol(To determine & compare the secondary implant stability quotient (ISQ) values of implants loaded using the progressive loading & conventional loading protocol)

研究者

发起方
Krishna Vishwa Vidhyapeet
申办方类型
Other [Deemed University]
责任方
Principal Investigator
主要研究者

Dr Shubha Joshi

Krishna Vishwa Vidhyapeet Deemed to be University

研究点 (1)

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