Prospective, Comparative Assessment of Single-tooth Replacement in Different Implant-abutment Settings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 4
- 主要终点
- Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
研究概览
简要总结
The primary objective is to compare the gum response to three different dental implant designs when placed in the front region of the upper jaw. The changes from baseline to one year after will be compared. The null-hypothesis is that the buccal soft tissue (gum) changes from baseline to one year after are equal for all three implant-abutment interface settings.
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
- 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
- 否
入选标准
- •Provision of informed consent
- •At least 18 years
- •In need of one or more single implants replacing missing or non-restorable teeth in the maxilla within region 14 to 24
- •The following should be considered at inclusion but can not be fulfilled until at Visit 2:
- •Edentulous for at least 5 months at study site
- •A buccal-lingual bone width at study site of at least 5.5 mm
- •A mesial-distal bone level distance between adjacent teeth at study site of at least 5.5 mm
- •A keratinized mid-buccal mucosal height of at least 2 mm at study site
- •Teeth adjacent (mesial and distal) to study site must consist of two stable teeth on natural roots without signs of periodontal bone loss (>1 mm) and/or significant soft tissue loss
- •Teeth adjacent (mesial and distal) to study site must demonstrate a stable occlusal guidance that will allow non-functional disclusion in all eccentric positions
- •An opposing dentition with teeth, implants or prosthesis
排除标准
- •Insufficient interocclusal distance for implant placement and restoration at study site
- •Tooth adjacent (mesial and/or distal) to study site is ankylosed
- •More than 2 mm vertical bone loss at study site as measured from the mid-buccal crest of bone on the adjacent teeth
- •Site development (bone tissue) performed at less than 5 months before Visit 2 at study site
- •Untreated rampant caries and/or uncontrolled periodontal disease
- •Class II division 2 malocclusion (Edward Hartley Angle)
- •Use of tobacco within last 6 months
- •Uncontrolled diabetes (subjects history does not reveal the absence of control of insulin-dependent/non-insulin dependent Diabetes Mellitus)
- •Current alcohol or drug abuse
- •Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Use of any substance that will influence bone metabolism
- •Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
- •History of radiation in the head and neck region
- •Known pregnancy, pregnancy tests will be performed as per local requirements.
- •Unable or unwilling to return for follow-up visits for a period of 5 years
- •Unlikely to be able to comply with study procedures according to Investigators judgement
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff or staff at the study center)
- •Previous enrollment or randomization of treatment in the present study.
研究组 & 干预措施
A
干预措施: OsseoSpeed™ (Device)
B
干预措施: NobelSpeedy™ Replace® (Device)
C
干预措施: NanoTite™ Certain® PREVAIL® (Device)
结局指标
主要结局
Buccal Soft Tissue (Gum) Changes, Measured as Mid-buccal Gingival Zenith (GZ) Scores.
时间窗: Evaluated at time of loading (permanent restoration) and at the 5-years follow-up after loading
Soft tissue response was evaluated by measuring it clinically and by evaluating it from clinical photographs using image analysis. Clinical evaluations of gingival zenith were performed at time of loading (permanent restoration) and at the 5-year follow-up after loading. The vertical distance from the most apical aspect of the soft tissue margin to the incisal edge of implant crown was measured using a standardized periodontal probe to the nearest half millimeter using the surgical loupe. The changes in the gingival zenith was calculated for each study position and the average for each treatment group was calculated for the evaluation period.
次要结局
- Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD(Measured at time of loading of permanent restoration and at the 5-year follow-up.)
- Marginal Bone Level Alterations(Evaluated at time of implant installation and at the 5-year follow-up visit.)
- Evaluation of the Periimplant Mucosa Condition - By Assessment of Change in BoP.(Measured at the implant loading and at the 5-year follow-up after loading.)