Bone-To-Implant Contact At 4- And 6-Week Healing Stages in Implants Having Either Machined, SLA Medium Roughness, Nanostructured Calcium-Incorporated or Plasma Reactivated Nanostructured Calcium-Incorporated Surface: A Histologic Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Bone to implant contact
研究概览
简要总结
Objective: Implant surface topography is a key element in achieving osseointegration. Nanostructured surfaces have shown promising results in accelerating and improving bone healing around dental implants. The main objective of the present clinical study is to compare, at 4 and 6w, bone-to-implant contact in implants having either machined surface (MAC), SLA medium roughness surface or a Nanostructured Calcium-Incorporated surface (XPEED®). Thirty five mini-implants with 3 different surface treatments (XPEED® (n=16) - SLA (n=13) - Machined (n=6)), were placed in the posterior maxilla of 11 patients then retrieved at either 4 or 6w in a randomized split-mouth study design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Height of the residual bone crest in the programmed implant site ≥ 9 mm and thickness ≥ 7mm.
- •Availability, in each sector, of sufficient mesio-distal space allowing placement of 2 standard-sized implants and at least 2 mini-implants (3.5x8.5mm) for retrieval.
- •Healed bone crest (≥ 3 months elapsed after extraction or tooth loss).
- •Age > 18 years.
- •Ability to examine and fully understand the study protocol.
排除标准
- •• Myocardial infarction within the past 6 months.
- •Poorly controlled diabetes (HBA1c > 7.5%).
- •Coagulation disorders.
- •Radiotherapy to the head/neck area within the past two years.
- •Present or past treatment with intravenous bisphosphonates.
- •Immunocompromised patients.
- •Psychological or psychiatric problems.
- •Alcohol or drug abuse.
- •Poor oral hygiene and motivation (full mouth plaque score > 30% and/or full mouth bleeding score > 20%).
- •Uncontrolled periodontal disease.
结局指标
主要结局
Bone to implant contact
时间窗: 6 weeks healing period after implant placement
Histology technique on specimen retrieved containing mini-implants and bone surrounding it
次要结局
未报告次要终点
研究者
Christian Makari
Associate Professor
Saint-Joseph University