NCT00807456已完成不适用
A Prospective, Open, Single Arm, Multi-center Study to Evaluate Maintenance of Lingual Bone in Healed Ridges With the ASTRA TECH Implant System, OsseoSpeed™ Profile Implant. A 3-year Follow-up Study
Dentsply Sirona Implants and Consumables10 个研究点 分布在 3 个国家目标入组 65 人开始时间: 2008年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 10
- 主要终点
- Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
研究概览
简要总结
The study aims to evaluate maintenance of lingual/palatinal marginal bone with the (ASTRA TECH Implant System) OsseoSpeed™ Profile implant in sites where the alveolar crest anatomy is sloped in a lingual to buccal direction.
The hypothesis is that the sloped marginal contour of the implant will help preserve the lingual/palatinal marginal bone.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Aged 18-75 years at enrolment
- •A lingual-buccal difference in bone height between 2.0-5.0 mm at the implant site
- •History of edentulism in the study area of at least 3 months
- •Presence of alveolar bone crest dimensions judged by the investigator to allow ≥1mm of bone circumferential to the implant after implant placement.
- •In need for a single implant replacing a missing tooth in any location with an adjacent natural tooth mesially, and an adjacent natural tooth or edentulous space distally to the planned implant position (i.e. no existing or planned implant adjacent to the planned study implant position)
- •Deemed by the investigator as likely to present an initially stable implant situation
排除标准
- •Uncontrolled pathological processes in the oral cavity
- •Known or suspected current malignancy
- •History of radiation therapy in the head and neck region
- •History of chemotherapy within 5 years prior to surgery
- •Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Uncontrolled diabetes mellitus
- •Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •Smoking more than 10 cigarettes per day
- •Present alcohol and/or drug abuse
- •Current need for bone grafting in the planned implant area
- •Previous enrolment in the present study
- •Simultaneous participation in another clinical study or participation in a clinical study during the last 6 months
- •Involvement in the planning and conduct of the study (applies to both Sponsor staff or staff at the study site)
- •Unlikely to be able to comply with study procedures, as judged by the investigator
结局指标
主要结局
Bone Level Changes at the Lingual Aspect From Implant Placement (Baseline) to Re-entry 16 Weeks After Implant Placement
时间窗: At baseline and 16 weeks
Clinical measurements after implant installation and after 16 weeks to determine bone levels at the buccal and lingual aspects in relation to a fixed landmark on the implant, i.e. the interface between the micro-threaded part and the shoulder at the marginal portion of the implants.The assessments were made using a periodontal probe and distances were measured to the nearest 0.5 mm. Negative value denotes loss of bone.
次要结局
- Condition of Peri-implant Tissues Measured by Average Change in Probing Pocket Depth (PPD) From Permanent Restoration(Baseline and 12 months, 24 months, and 36 months post implant placement)
- Marginal Bone Level (MBL) Change From Implant Placement Presented on Implant Level(Baseline and 16 weeks, 21 weeks, 12 months, and 36 months post implant placement)
- Condition of Peri-Implant Tissues Measured Through Bleeding on Probing (BoP)(21 weeks, 12 months, 24 months, and 36 months post implant placement)
- Condition of Peri-implant Tissues Measured by Average Change in Clinical Attachment Level (CAL) From Permanent Restoration(Baseline and 12 months, 24 months, and 36 months post implant placement)
- Implant Survival Rate(21 weeks, 12 months, 24 months and 36 months post implant placement.)
研究者
研究点 (10)
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