Clinical Performance of Dental Implants With Hydrophilic or Hydrophobic Surfaces in Single Posterior Edentulous Spaces: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change of implant stability
研究概览
简要总结
The aim of the study is to compare longitudinally the clinical performance of dental implants with different surfaces placed in single tooth gaps at the posterior maxilla and mandible of adults. It is a randomized clinical trial, in which participants will be randomly allocated to two groups: test group (implants with hydrophilic surface) and control group (implants with hydrophobic surface). The null hypothesis is that the implant stability quotient of hydrophilic and hydrophobic dental implants show a similar progression after placement in posterior tooth gaps.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Present single or multiple intercalated untreated tooth gaps in the posterior region of the mandible or maxilla;
- •Agree to participate in the study by signing the informed consent form.
排除标准
- •Unavailability for participation or signs that they could not comply with the schedule of follow-up visits;
- •Presence of general and/or local contraindications that could prevent the surgical procedure for implant placement;
- •Presence of conditions that may interfere with the prognosis, such as current treatment with bisphosphonates or report of use for less than 2 years, presence of rheumatic diseases, among others;
- •Absence of the minimum bone quantity of 8 mm in length and 3.75 mm in diameter for installation of an implant in the tooth gap;
- •Absence of a mesio-distal space of at least 4.6 mm in the single tooth gap required to place the surgical guide;
- •Do not present a mouth opening of at least 12mm required for the proper of the guided surgical kit together with the surgical guide;
- •Do not present a band of keratinized tissue favorable for maintaining peri-implant health.
- •Present motor difficulties that compromise adequate oral hygiene.
结局指标
主要结局
Change of implant stability
时间窗: 10 time-points will be considered and divided in two phases: surgical and prosthetic. The last measure will occur 1 year after the placement of the definitive implant restoration.
Implant stability was set as the primary outcome. The implant stability quotient (ISQ) will be measured using a portable device called Osstell ISQ (Osstell Mentor, Integration Diagnostics, Göteborg, Sweden).
次要结局
- Implant success(Assessed at the 12-month follow-up visit.)
- Periimplant bone level(Radiographs will be obtained at 4 time points: immediately after implant placement, at the session of the provisional prosthesis installation, and at the 6 and 12-month follow-up visits after the delivery of the definitive prosthesis.)
- Condition of the periimplant soft tissues(15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.)
研究者
Cláudio Rodrigues Leles
Full Professor
Universidade Federal de Goias