Immediate Placement and Temporization of Tapered Implants in Extraction Sockets or Early Implant Placement Protocol? A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes of pink aesthetic score (PES) over time
研究概览
简要总结
The purpose of this randomized clinical trial, of 50 patients in need of a maxillary anterior implant, was to assess the esthetic outcomes of immediate temporization of immediately placed tapered implants in fresh extraction sockets with soft tissue and bone augmentation as compared to early placed implants with conventional loading. Secondary objectives included the influence of immediate provisionalization on the success rate of tapered implants and crestal bone stability.
详细描述
Patients with a failing maxillary anterior tooth were included in this study. After atraumatic extraction, test group patients received an immediate implant with provisional restoration, while patients in the control group received an implant after 6 weeks of healing. After 4 months (test group) and 6 months (control group) definitive restorations were delivered. All patients were followed for 1 year post restoration and pink esthetic score (PES), mid-buccal mucosal level (MBML), crestal bone changes (CBC) and peri-implant soft tissue parameters were recorded at several time points. In addition, patient chair time was recorded.
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 (Participant)
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
- •no recession of gingival contour of tooth to be extracted,
- •no periodontal bone loss of neighboring anterior teeth,
- •no implants in neighboring teeth,
- •class I extraction socket (intact buccal wall),
- •atraumatic extraction of the tooth with intact socket walls remaining,
- •only one implant per patient to be inserted.
排除标准
- •deep bite (severe II class),
- •systemic disease (diabetes, osteoporosis),
- •heavy smokers (more than 10 cigarettes/day) were excluded.
- •atraumatic extraction of the tooth failed,
- •the primary stability (at least 25 Ncm) needed for implant temporization, after implant placement, was not achieved.
结局指标
主要结局
Changes of pink aesthetic score (PES) over time
时间窗: Baseline, 1 year and 5 years after prosthetic delivery
pink esthetic score means evaluation of seven parameters of anterior tooth aesthetics - mesial and distal papila, soft tissue level, contour, texture, color and convexity. Each parameter may be evaluated by score 0,1 or 2, were the score 0 means the worst outcome, 2 - the best. Evaluation will be performed visually using digital photos.
次要结局
- Changes of marginal bone level (MBL) around implant neck(Baseline, 1 year and 5 years after prosthetic delivery)
- Recession changes of gingiva of restored tooth on the implant(Baseline, 1 year and 5 years after prosthetic delivery)
研究者
Algirdas Puisys, DDS, PhD
Principal investigator
Vilniaus Implantologijos Centro (VIC) Klinika