Linear and Volumetric Analysis on the Effect of Customized Healing Abutments at Maxillary Immediate Implant Sites: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Buccal volume variation (BVv)
研究概览
简要总结
Studies evaluating the use of customized healing screws/abutments in immediate implant placement have been performed, aiming to assess possible advantages with the use of this treatment modality. Despite the existence of these investigations, there is a lack of information regarding a digital approach to evaluate in an objective manner soft and hard tissue dimensional changes at this treatment modality.
详细描述
Studies evaluating the use of customized healing screws/abutments have been performed aiming to assess possible advantages with the use of this treatment modality. Despite the existence of these investigations, there is a lack of information regarding a digital approach to evaluate in an objective manner soft and hard tissue dimensional changes.
The aim of this study is to perform a volumetric analysis evaluating peri-implant tissues dimensional changes on the effect of using customized healing abutments compared with the use of collagen matrices as socket sealing options in maxillary immediate implant placement.
The present study was designed as a prospective, randomized, controlled clinical trial with a parallel-group design, to document the response of using a customized healing abutment in maxillary immediate implants. Twenty-eight consecutive patients in need of a single implant restoration in the maxillary arch following tooth extraction were included in this study.
All patients were treated with cylindrical shape implants (OsseoSpeed EV™, AstraTech Implant System, Dentsply Implants, Möhndal, Sweden) with a narrow diameter internal connection platform following the surgical sequence protocol provided by the manufacturer. The implant was placed in a correct three-dimensional position, engaging the palatal and apical bone to achieve high primary stability. (Buser et al. 2004) After implant insertion, a gap of at least 2 mm between the inner cortical buccal bone plate and the implant surface was filled with DBBM material (Symbios®, Dentsply Implants, Möhndal, Sweden).
The two groups differ in the type of socket sealing. Control group fresh sockets were sealed with a resorbable collagen membrane (Mucograf Seal®, Geistlish Biomaterials, Wolhusen, Switzerland) stabilised with single interrupted 6/0 polyamide sutures (SeralonTM, Serag-Wiessner, Nalia, Germany), whereas test group received a healing abutment customized with a composite resin material allowing to close the socket without sutures.
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
- Single (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
- •patients with ≥18 years of age;
- •patients who had a failing tooth and needed an implant placing therapy in the aesthetic zone (between 15-25);
- •the failing tooth has adjacent and opposing natural teeth;
- •sufficient mesial-distal and inter-occlusal space for placement of the implant and definitive restoration;
- •had an intact socket wall previously to the extraction;
- •had sufficient apical bone to place an immediate implant with minimum primary stability of 30 N/cm.
排除标准
- •individuals diagnosed with periodontal disease;
- •medical and general contraindications for the surgical procedure;
- •heavy smokers (> 10 cigarettes/day); .an active infection at the implant site.
结局指标
主要结局
Buccal volume variation (BVv)
时间窗: Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)
Variation of the alveolar volume at the buccal aspect. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Buccal Volume Variation (BVv0-1, BVv0-2, and BVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0.
Total volume variation (TVv)
时间窗: Baseline (T0); 1 month (T1); 4 months (T2) and 12 months (T3)
Variation of the alveolar volume at the buccal and palatal side. The 3D-analysis was conducted with "Boolean" functions, which allowed researchers to obtain the volume variation in each time point from different variables like the Total Volume Variation (TVv0-1, TVv0-2, e TVv0-3), computed in cubic millimetres (mm3) and To allow a direct comparison of different sites at different time points, relative percentages of these variables were calculated based on the ROI volume at T0
次要结局
- Buccal wall thickness (BT)(baseline)
研究者
Tiago Borges
Professor
Universidade Católica Portuguesa