The Influence of a Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) on the Aesthetic Outcome After Immediate Placement and Loading of a Tapered Dental Implant in the Anterior Maxilla. 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
- Aesthetic evaluation
研究概览
简要总结
Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. However, the evidence that this immediate provisialisation with soft tissue grafting using different grafting materials results in constantly high Pink Esthetic scores, especially compared to the delayed loading approach is still lacking.
The aim of this clinical trial is to assess the esthetic outcome of immediate temporization of immediately placed and loaded tapered implants in fresh extraction sockets with bone and soft tissue augmentation, using either a connective tissue graft (CTG) or a porcine-derived membrane (Mucoderm) in maxillary anterior sites.
The secondary objectives are to investigate the influence of immediate loading on the success rate of tapered implants and crestal bone levels.
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
- •Males and females of at least 18 years of age
- •1 implant per patient
- •Subject must have voluntarily signed the informed consent before any study related action, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed
- •Anterior single teeth (canines and incisors) in both jaws
- •Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)
- •No recession of gingival contour of tooth to be extracted
- •No periodontal bone loss of neighboring anterior teeth
- •No implants in neighboring teeth
- •Atraumatic extraction of the tooth with intact socket walls remaining
排除标准
- •Deep bite (severe II class)
- •Heavy smokers (more than 10 cigarettes/day)
- •Systemic disease (diabetes, osteoporosis)
- •Primary stability after implant placement not achieved
结局指标
主要结局
Aesthetic evaluation
时间窗: Change from baseline, 1 year, 5 and 10 years after prosthetic delivery
Pink esthetic score (PES) according to Fürhauser et al. 2005 Seven variables will be evaluated: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14. For the PES assessment, frontal photographs will be taken using a digital camera with a flash strobe mounted on a tripod (Canon 350d, 3456×2304 pixel resolution). PES will be assessed at baseline (Final Prosthesis), 3- and 12-month visit.
次要结局
- Recession of gingiva (REC)(Change from baseline, 1 year, 5 and 10 years after prosthetic delivery)