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临床试验/CTRI/2024/03/064899
CTRI/2024/03/064899
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Evaluation of the Effect of Two Different Implant Thread Designs on Implant Stability in Immediate Functional Loading Protocol - A Randomized Control Trial

Janvi Kalra1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年4月12日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Janvi Kalra
入组人数
26
试验地点
1
主要终点
To evaluate implant stability quotient in Dynamic Progressive implant thread design (Neodent® Helix GM® Implants) in functionally loaded implants at baseline, 3 months and 6 months post-loading.

概览

简要总结

·       Implant dentistry has evolved from the conventional healing protocol of 3–6 months to the most recent trends of immediate and early loading of implants.

·       Good implant stability is fundamental to the success of immediate functional loading.

·       Primary stability of the dental implant is achieved through a good mechanical fixation of the dental implant within the bone, whereas secondary stability is achieved due to biological integration.

·       Implants with varying characteristics and macro-geometry show different biomechanical behaviours, which lead to differences in the stability of the implant.

·       It is necessary to understand the individual response of each implant thread design in terms of primary and secondary stability.

·       During the early phases of healing, the micromovements of the implant should not exceed values ranging between 50 and 150 µm for predictable osseointegration.

·       These values can be observed by methods such as Periotest, Insertion Torque, Resonance Frequency Analysis and Radiography.

·       The purpose of this study is to compare implant stability using Immediate functional loading protocol in two implant systems with different thread designs.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Double

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with single missing posterior tooth in mandibular arch.
  • Patients within the age group of 20-45 years of either sex.
  • Patients with D2 bone quality (850-1250 Hounsfield Units).
  • Patients with sufficient vertical inter arch space to accommodate the prosthetic component.

排除标准

  • Patients having known history of bone disorders (e.g. osteoporosis, osteoarthritis).
  • Patients having known systemic diseases contraindicated for implant placement.
  • Patients with a history of smoking.
  • Patients with a history of drug intake such as immunosuppressive drugs, anticoagulants and anti-cancer drugs three months prior to the study.
  • Patients undergoing orthodontic treatment.
  • Pregnant and lactating women.

结局指标

主要结局

To evaluate implant stability quotient in Dynamic Progressive implant thread design (Neodent® Helix GM® Implants) in functionally loaded implants at baseline, 3 months and 6 months post-loading.

时间窗: baseline, 3 months, 6 months

To evaluate implant stability quotient in Optimized implant thread design (IntEssence Refirm® Implants) in functionally loaded implants at baseline, 3 months and 6 months post-loading.

时间窗: baseline, 3 months, 6 months

To compare the implant stability quotient values obtained in Dynamic Progressive implant thread design and Optimized implant thread design in functionally loaded implants at baseline, 3 months and 6 months post-loading.

时间窗: baseline, 3 months, 6 months

次要结局

  • N/A(N/A)

研究者

发起方
Janvi Kalra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Janvi Kalra

Manav Rachna Dental College

研究点 (1)

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