临床试验/CTRI/2021/07/034617

CTRI/2021/07/034617尚未招募4 期

"EVALUATION OF CRESTAL BONE LEVELS USING SIMVASTATIN AS AN ADJUVANT AROUND IMMEDIATE IMPLANTS- A CLINICO-RADIOGRAPHIC STUDY".

hymasree betha1 个研究点分布在 1 个国家目标入组 14 人开始时间: 2021年7月22日最近更新: 2021年5月7日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 14
试验地点: 1
主要终点: peri implant crestal bone level around immediate implants.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The peri implant bone loss immediately after implant placement is a significant phenomenon.

2.The preservation of crestal bone is considered as a key feature for the success of the treatment given that the bone around the implant determines the stability of the soft tissue, which in turn is a crucial aspect for esthetics and long-term survival.

3.There are many proven animal studies on the positive effects and bone inducing properties of simvastatin around implants.

4.so ,the present study is planned on humans to know the effectiveness of simvastatin as an adjuvant on crestal bone levels in immediate loaded implants after extraction.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 55.00 Year(s)（—）
性别: All

入选标准

•1.Age between 18-55 years 2.Good general health 3.Adequate quality and quantity of bone & Good oral hygiene status 4.Presence of non- restorable teeth due to trauma, caries, root resorption, root fracture, endodontic failure.

排除标准

•1.Uncontrolled diabetes measured with HbA1c levels 2.Pregnancy 3.Poor oral hygiene 4.Treatment with a bisphosphonate drug
•Severe bruxism and clenching ïƒ˜Active infection or severe inflammation at proposed implant site.

结局指标

主要结局

peri implant crestal bone level around immediate implants.

时间窗: BASELINE,3 MONTHS,9 MONTHS

次要结局

peri implant bone volume(cu.mm of bone volume around implant at baseline and after 9 months of placement)

研究者

发起方

hymasree betha

申办方类型

Other [self]

研究点 (1)

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