Replacement of Individual Teeth in the Esthetic Zone of Upper Jaw by Using a Monoblock Ceramic Implant: One Year Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Marginal bone level change (MBLC)
研究概览
简要总结
The main objective is to evaluate peri-implant hard and soft tissues's stability with the use of a ceramic implant (Implant Straumann®Pure Ceramic) during one year follow up.
详细描述
Nowadays, the material of choice for the manufacture of dental implants is titanium. However, if we consider the aesthetics, the use of metallic implants can lead to complications, namely metal translucency through the peri-implant mucosa or the presence of soft tissue recessions causing metal exposure. As an alternative to the use of titanium, we have zirconium, that is highly biocompatible and whose use in implantology has demonstrated a predictable osseointegration. In addition, some studies suggest a different histology that could help maintaining the stability of the peri-implant mucosa and, therefore, an improvement in long-term aesthetic results.
The reason for designing this study is that there is not too much data about this type of implants, that can be, really, an alternative to those we know.
To achieve those objectives a single-arm clinical trial is designed, using marginal bone loss as a primary response variable. It is estimated with the calculation of the sample size, we would need 30 patients to get relevant data.
An experienced surgeon (M.V) will perform implant surgery. Later, experienced and calibrated examiners (R.E and E.RG) will collect the following clinical parameters at baseline, and at 4, 8 and 12 months: gingival recession, papillary Jemt index, width and height of the keratinized gingiva, probing depth, plaque index and bleeding on probing.
Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as unit of analysis the implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients of the Master of Periodontology of the UPV/EHU
- •Age > 18 years
- •Patient with one single tooth gap in the anterior maxilla
- •Plaque and bleeding index (FMPS < 20%).
- •Treated periodontal conditions
- •The patient is able to fully understand the nature of the proposed surgery and is able to provide a signed informed consent
排除标准
- •General contraindications for dental and/or surgical treatment are present.
- •The patient is taking medications or having treatments which have an effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
- •Untreated periodontal conditions
- •Patients not willing to participate
结局指标
主要结局
Marginal bone level change (MBLC)
时间窗: Change from baseline until 12 months
Distance between the mesial/distal marginal crests and the first implant thread. This is calibrated based on the known length (1,8 mm) of the machined neck.
次要结局
- Gingival recession (REC)(Change from baseline (when the crown is cemented) until 12 months.)
- Jemt Papilla index score (JPIS)(Change from baseline until 12 months.)
- Bleeding on probing (BOP)(Baseline, 4, 8 and 12 months.)
- Plaque index (PI)(Baseline, 4, 8 and 12 months.)
- Width of keratinized tissue (WKT)(Baseline and 12 months.)
- Thickness of keratinized tissue (TKT)(Baseline and 12 months)
- Surgical complications (SC)(Surgery and the next 7 days.)
- Prosthetic complications (PC)(Baseline, 4, 8 and 12 months.)
- Probing depth (PD)(Baseline, 4, 8 and 12 months.)
研究者
Miren Vilor Fernández
Principal Investigator
University of the Basque Country (UPV/EHU)