Stability of Implants With Different Surface Treatment: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- implant loss
研究概览
简要总结
Objectives: To compare the stability of implant surface treated by dual acid etching (Porous)and implants with anodized surface (Vulcano) over a period of 16 weeks after installation.
Methods: it will be a clinical study with individuals with missing teeth requiring rehabilitation with dental implants in the maxilla and that fulfill the study inclusion criteria. The research sites will be randomized into two groups: the control group patient's sites receive implant surface treated by dual acid (AR Torque Porous, Connection Implant Systems, Aruja, Brazil) and in the test group implants with anodized surface (AR Torque Vulcano-Actives, Connection Implant Systems, Aruja, Brazil). The evaluation of the stability of the implants will be made over 16 weeks, through resonance frequency analysis with Osstell (Integration Diagnostics AB, Gothenburg, Sweden). Data will be analyzed using descriptive statistics and comparative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have missing teeth in the maxilla,
- •over 30 years old and under 60 years old,
- •the implant sites with at least 3 months of healing after extraction,
- •the implant sites with width and length to installation of an implant of 4 mm x 10 mm.
排除标准
- •patients who experience any of the following conditions:
- •general contraindications for surgical procedures,
- •uncontrolled diabetes,
- •severe bruxism or clenching,
- •pregnant and lactating women,
- •active periodontal disease,
- •smoker and user of alcohol or drugs.
研究组 & 干预措施
Vulcano Actives
Implants 4mm x 10mm Vulcano Actives (anodized surface)(AR Torque Vulcano actives), Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla
干预措施: RFA (Device)
Porous
Implants 4mm x 10mm Porous (dual acid-etched surface treatment)(AR Torque Porous, Conexão Sistemas de Prótese, Arujá, Brasil)will be placed on edentulous area in maxilla
干预措施: RFA (Device)
结局指标
主要结局
implant loss
时间窗: 4 months
During the osseointegration, if the implant lose his stability and if it show spin and if the patient have pain, the implant will be removed and the implant will be considered lost
次要结局
- ISQ analysis(6 months)
研究者
Érico Castaldin Fraga Moreira
Master of Science
University of Sao Paulo