Evaluation of the Stability of Implants With Two Different Surface Treatments: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Loss of implant
研究概览
简要总结
The aim of this study is to compare the stability of dental implant surface treated by sandblasting abrasive particles and acid subtraction (Control) with hydrophilic surfaces dental implants (chemical) and with a higher surface energy (Test) for a period of 16 weeks after installation. The evaluation will be made by analyzing the resonance frequency (Ostell). The hypothesis to be tested will be that implants with hydrophilic surface show increased secondary stability prior to the implants treated by acid etching.
详细描述
The selected patients will be randomly divided into two groups by computer-generated list. The control group will receive implant surface treated by acid etching and test group receive implants with hydrophilic surface (Test). Both the test and the control group will undergo the same pre-surgical, surgical and post-surgical protocols.
The evaluation of the implant will be done by the analysis of resonant frequency wich will be performed on each implant with Osstell (Integration Diagnostics AB, Goteborg, Sweden) immediately after implant placement (baseline) and at follow-up sessions (1st, 2nd, 3rd, 5th, 8th, 12th and 16th weeks after installation) and coefficient of implant stability (ISQ) on these dates will be measured on a scale from 0 to 100. The smartpeg be used with special developed Healing without the use of pillars or intermediaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who had lost teeth in the posterior maxilla (region of premolars and molars, can be interspace or free end) in need of restoration with implant-supported prostheses
- •Able to understand and sign a waiver of informed free consent
- •Good oral hygiene
- •The receiving implant sites must have at least 3 months of healing after tooth extraction, proper height and width to install an implant of 4.3 mm in diameter and 10 mm of high.
排除标准
- •Patients requiring implants in the mandible or anterior maxilla (bone type I and II), or to submit any of the following conditions: general contraindications for surgical procedures, uncontrolled diabetes, severe bruxism or clenching, pregnant and lactating women, active periodontal disease, smoking and use of alcohol or drugs
- •Patients who underwent radiotherapy near the buccal cavity regions chemotherapy and those who use or have recently used bisphosphonates, such as alendronate.
研究组 & 干预措施
Experimental Group
At this group the patients will receive dental implants which have a modified SLA surface. These surface have wettability, which could improve and accelerate the osseointegration.Intervention: implant placement.
干预措施: Implant surgery (Procedure)
Control Group
The patient of this group will receive implant with conventional surface, SLA (Sandblasted and Acid-Etched Surface).Intervention: implant placement.
干预措施: Implant surgery (Procedure)
结局指标
主要结局
Loss of implant
时间窗: 4 months after surgery
If the implant has been not integrated to the bone!
次要结局
- Implant stability (ISQ)(Baseline, 1 to 16 weeks (4 months))
研究者
Marcelo Michele Novellino
PHD Student
University of Sao Paulo