Evaluation of a Bioactive Surface in Post-extraction Sites: Case Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Marginal bone loss
研究概览
简要总结
In this case-control study a bioactive implant surface was compared with traditional surfaced implants. Primary objectives: Test the implant stability in post-extractive sites, comparing traditional surfaced implants (MultiNeO CS, control group) to bioactive surfaced implants (NINA- MultiNeO NH, treatment group).
Primary outcome endpoints were Implant stability, assessed through Implant stability quotient (ISQ) values and Marginal bone loss (MBL)
详细描述
In this post- market case control study, the tested CE-marked dental implants are MultiNeO CS 1930 and NINA MultiNeO NH 9330, both manufactured by Alpha-Bio Tec. .
Alpha-Bio Tec. implants systems are made of Ti-6AI-4V ELI Titanium alloy which is a high-performance and highly biocompatible alloy for manufacturing bone implants. Alpha-Bio Tec developed the superior NanoTec&trade implant surface for optimized osseointegration process. Alpha-Bio Tec NanoTec™ implant surface is achieved by a complex process of large particle sandblasting and acid etching. Sandblasting with large particles allows the creation of macropores (20-40 microns), while the double etching allows the creation of micropores (1-5 microns). The micro - structure and roughness properties of NanoTec™ Implant Surface greatly influences the dynamic wettability of implant surfaces during the initial contact with the host.
The overwritten implant surface enables greater absorption of blood and plasma proteins directly inside the micropores, immediately after the implant has been placed.
It is the implant surface of MultiNeO. NeO or MultiNeO is defined as a system since it includes three types of connections: a conical narrow connection (CHC), a conical standard conical connection (CS) and an Internal Hex connection (IH). the fixture has a straight coronal part, a slightly tapered body and a conical apical part. We will use MultiNeO CS in control group. One of the MultiNeO biggest clinical advantages since it is as good at bone type 4 as it is at bone type 1, 2 or 3.
Topography and surface roughness of MultiNeO lead to some clinical advantages:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with type 1-2 post extraction sites
- •Subject is 30-80 years old
- •Patient ASA 1 or 2
- •Patients with healthy periodontal conditions (Treated periodontitis, PI<25%, BoP<25%)
- •Patients that are willing to sign an informed consent and participate in a clinical study
排除标准
- •Absence Type 1-2 post extraction sites
- •Patient ASA 3 or 4
- •Untreated Periodontitis
- •Any sites where an implant already failed sites
- •Allergy declared to one or more medicaments to be used during treatment
- •Pregnancy (confirmed by verbal inquiry)
结局指标
主要结局
Marginal bone loss
时间窗: 12 months after implant placement
Radiographic evaluation of the marignal bone level around the implant using a periapical x ray. marginal bone loss is in millimeters and indicates how many millimeters of bone has been lost
Implant stability
时间窗: 45 days after implant placement
check implant stability using resonant frequency analysis (RFA)
次要结局
- insertion torque curve(During implant placement (T0 baseline))
研究者
Luigi Canullo
Principal investigator
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo