The Influence of Abutment Macro-design on Peri-implant Tissue Dimensions for Guided Placed and Restored Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Peri-implant mucosa margin position change
研究概览
简要总结
The aim of this study is to evaluate the effect of abutment macro-design on soft and hard tissue responses. This trial is designed as a randomized controlled clinical study in which two groups of fourteen partially edentulous patients will have as part of their treatment one implant placed in the maxillary premolar region.
详细描述
Implant placement and abutment design will be planned with a computer software for guided implant treatment (SIMPLANT). The surgical implant placement will be performed under manufacturer's protocol by placing the implant platform 1mm below the buccal aspect of the osteotomy (Koutouzis et al 2013). Virtually designed, permanent CAD-CAM fabricated abutments (ATLANTIS, DENTSPLY) with different configuration of the subcritical contour (emergence shape) will be connected to the implants and temporary crowns will be delivered.
Implants of the Group 1 will have permanent abutments with a concave configuration of the subcritical contour (emergence shape).
Implants of the Group 2 will have permanent abutments with a convex configuration of the subcritical contour (emergence shape).
The patients will be restored with single crowns 3 months following implant installation.
A randomization protocol will be produced from a computer-generated list for the distribution of subjects in the two treatment groups.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General Inclusion criteria:
- •- Age more than 21 years
- •Absence of relevant medical conditions
- •Availability for 12 month follow-up
- •Specific Inclusion criteria:
- •One missing tooth in the maxillary premolar region
- •Presence of two adjacent teeth at the implant site
- •Absence of periodontal disease
- •Healed osseous architecture enough to receive an implant with a diameter of at least 3.5 mm and a sufficient amount of bone for placing implants with a length of at least 9 mm
排除标准
- •- Pregnancy at the screening visit.
- •Smoking more than 10 cig/day
- •Specific Exclusion criteria:
- •Adjacent implants
- •Presence of periapical radiolucency at the adjacent teeth
- •Missing adjacent teeth
研究组 & 干预措施
Group 1
Abutments with a concave configuration of the subcritical contour (emergence shape).
干预措施: Abutment with concave subcritical contour (Other)
Group 2
Abutments with convex configuration of the subcritical contour (emergence shape)
干预措施: Abutment with convex subcritical contour (Other)
结局指标
主要结局
Peri-implant mucosa margin position change
时间窗: Day 7-10 to the Day 360
The primary outcome variable will be change on peri-implant mucosa margin position.
次要结局
未报告次要终点
研究者
Theofilos Koutouzis
Associate Professor
Nova Southeastern University