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临床试验/CTRI/2024/03/063828
CTRI/2024/03/063828已完成4 期

Comparative evaluation of inflammatory biomarkers in peri implant crevicular fluid and crestal bone loss in two different implant collar designs at different time intervals:A clinical study

Dr.Paulina1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年3月15日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
1. To evaluate the effect of Micro-Thread Collar Design on crestal bone levels and inflammatory biomarkers

研究概览

简要总结

New developments in implant design and surface technology have emerged to minimize crestal bone level changes. Since implant collar or crest module is a trans-osteal  portion of the implant that plays an important role in peri implant tissue’s health condition, so assessment of biomarker in Peri Implant Crevicular Fluid (PICF) is a valuable diagnostic tool to maintain peri-implant health around crest module. Although few studies are available but there is a lack of consensus regarding superior  retention of crestal bone levels by roughened collars when compared to smooth (machined) collars in human studies. There is  also paucity of literature on the correlation  of loss of crestal bone levels with inflammatory markers with relation to different collar designs. This study, therefore aims to compare the affect of collar design on crestal bone levels and inflammatory bio markers.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with one missing tooth in the posterior mandibular molar area Patients with good oral hygiene Patients with adequate bone height and width to accommodate implant of appropriate dimension Co-operative patient, willing to give consent.

排除标准

  • Patients with a known history of any systemic diseases Patients with a history of smoking Patients with a history of intake of immunosuppressive drugs, anticoagulants, and anti-cancer drugs three months prior to the study Patients with a history of radiotherapy Pregnant and lactating women.

结局指标

主要结局

1. To evaluate the effect of Micro-Thread Collar Design on crestal bone levels and inflammatory biomarkers

时间窗: At the time of implant placement, 3 months and 6 months post-implant placement.

2. To evaluate the effect of Smooth Collar Design on crestal bone levels and inflammatory biomarkers

时间窗: At the time of implant placement, 3 months and 6 months post-implant placement.

次要结局

未报告次要终点

研究者

发起方
Dr.Paulina
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DrPaulina

Manav Rachna Dental College

研究点 (1)

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