Clinical and Radiographic Evaluation of the Marginal Bone and Soft Tissue Alterations After the Treatment With Use of OsseoSpeed EV Profile Implants: A Case Series Study
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
- Pink Esthetic Score (PES) at Temporary Crown Delivery.
研究概览
简要总结
Evaluation of the marginal bone and soft tissue alterations after the OsseoSpeed™ EV Profile implants placement in anterior maxilla.
The following parameters will be tested:
- pink esthetic score - at the temporary crown delivery, at the final crown delivery, 6 months post final crown delivery
- papilla index - at the temporary crown delivery, at the final crown delivery, 6 months post final crown delivery
- changes in radiographic marginal bone levels and width at buccal and palatal aspects: differences between baseline (the day of surgery) and 1-year post-op measurements on CBCT will be made.
详细描述
Surgical procedures
Flap will be elevated following the crestal and releasing incisions (if necessary).
After having completed the cleaning, the surgeon will perform the osteotomy. After the use of the final drill ᴓ3.2 the surgeon will take the measurement of the buccal and palatal/lingual walls height.
If wall discrepancy is 1.5-2mm the site will be included in the study. Clinical photographs of probe within the osteotomy have to be taken. The osteotomy will be prepared with the conical drill, therefore the implant will be inserted in a special manner - lower part of the sloped collar will be located at the buccal aspect of the osteotomy preparation. At the buccal aspect the implant will positioned at the crestal bone level, while at the palatal aspect it will be either at the level of the bone crest or 0.5 mm below.
The flap will be sutured with 5/0 or 6/0 non-absorbable Ethilon sutures using the mattress and single interrupted sutures. Clinical photographs of the treated site after flap suturing will be taken.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •lack of tooth in position of central incisors, canines and premolars
排除标准
- •Uncontrolled diabetes
- •Pregnancy or lactation
- •Poor oral hygiene
- •Compromised dentition neighboring to edentulous site
结局指标
主要结局
Pink Esthetic Score (PES) at Temporary Crown Delivery.
时间窗: value changes between examination carried out 3 and 9 months post-op
Pink Esthetic Score (PES): 0-10; minimum - 0, maximum - 10; the best outcome: 10 PES subscores: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, root convexity/soft tissue color and texture at the facial aspect of the implant site. Minimum 0, maximum - 2; the best outcome: 2
Papilla Index (PI) at Temporary Crown Delivery.
时间窗: value changes between examination carried out 3 and 9 months post-op
Papilla Index score: 0-4; the best outcome: 3; minimum: 0, maximum: 4 0 - no papilla present; 1 - less than half of the height of papilla present; 2 - half or more of the height of papilla is present but does not extend all the way up to the contact point between of the crowns; 3 - the papilla fill up the entire proximal space and is in good harmony with the adjacent palillae; 4 - the papilla is hyperplastic and covers too much of the implant restoration and/or the adjacent tooth
次要结局
- Cone Beam Computed Tomography Examination Taken Right After Implant Installation.(Assessed immediately after implantation and 12 months post-op)
研究者
Małgorzata Pietruska
professor
Medical University of Bialystok