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临床试验/NCT07199725
NCT07199725已完成2 期

Clinical and Radiographic Evaluation of Natural Bovine Bone With Hyaluronic Acid on Osseointegration of Immediate Implant: A Randomized Clinical Study

Suez Canal University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年11月8日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Bone density

研究概览

简要总结

the goal of this study is to evaluate the effective of natural bovine bone with hyaluronic acid on osseointegration of immediate implants in single rooted badly decayed maxillary anterior teeth and premolars. the main question it aims to answer is does natural bovine with hyaluronic acid affects osseointegration of immediate implants.

the study compares immediate implants followed by grafting with natural bovine bone with hyaluronic acid to immediate implants without grafting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •medically free patients, good oral hygiene, no periapical lesions around teeth to be extracted

排除标准

  • •patients with bone or soft tissue defects, poor oral hygiene, heavy smoking, bruxism, severe periodontal disease

研究组 & 干预措施

control group

Active Comparator

control group: 8 immediate implants were inserted in 8 fresh extraction sockets without bone grafting.

干预措施: immediate dental implant (Combination Product)

study group

Active Comparator

study group: 8 immediate implants were inserted in 8 fresh extraction sockets followed by grafting with natural bovine bone substitute material with hyaluronic acid

干预措施: immediate dental implant, natural bovine bone substitute material (Combination Product)

结局指标

主要结局

Bone density

时间窗: baseline (immediately) and 6 months

using cone beam CT bone density was measured around the implant in housefield units immediately after implant placement and after 6 months.

implant stability

时间窗: Baseline (immediately) and after 4 months

using Osstell device, implant stability was measured immediately after implant placement and after 4 months

次要结局

  • Bone width(Baseline (immediately) and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mohamed wageh foad

principal investigator

Suez Canal University

研究点 (1)

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