Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in the Anterior Part of the Mandible and Restored With Fixed Prostheses: a Randomized, Split-mouth, Masked, Prospective, Open, Comparison, Monocenter Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
研究概览
简要总结
Change in crestal bone level implants at 5% significance level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 80
- •male or female (female non-pregnant)
- •sufficient oral hygiene
- •no inflammation/disorder in the area of implant site
- •edentulous mandible and sufficient prosthetic and conservative
- •sufficient width and height of bone to place implants with diameters of 4.8mm and length of 11 mm
- •provide written informed consent
排除标准
- •demonstrate a need for pre-surgical bone or soft tissue augmentation in planned implant areas
- •exhibit angulation requirements of restoration exceeding 15 degrees
- •systemic metabolic disorder that would compromise post-operative tissue regeneration or osseointegration
- •taking medication that would compromise post-operative healing and/or osseointegration
- •bone disorders such as osteoporosis, hyperparathyroidism, Paget's disease, diabetes mellitus
- •oncology treatment
- •oral infection
- •acute gingivitis and/or periodontitis
- •local bone defects in the area of planned implantation
- •disorders of oral mucosa (e.g., leukoplakia, oral lichen, pemphigoid lesions)
- •received investigational drug within 30 days
- •history of illicit drugs or alcohol abuse
- •history of addiction to medication
- •allergic to dental materials
- •nicotine abuse (> 20 cigarettes/day)
- •pregnant or nursing
- •clinical significant or unstable medical or physiological conditions that would compromise participation in study
- •unable or unwilling to return for follow-up visits for a period of 24 months
研究组 & 干预措施
Ankylos dental implants.
3 Ankylos dental implants placed in platform switch configuration on one side of the mandible in support of a fixed restoration.
A total number of 19 subjects participated in this randomized, split mouth, masked, prospective, open, comparison, monocenter study. Participants were subjects with an edentulous mandible who recieved 3 implants on each side which were splinted for the delivery of a fixed prosthesis.
干预措施: Ankylos Implants (Device)
3i Prevail dental implants.
Three 3i Prevail dental implants placed on the opposite side of the mandible from the Ankylos implants in support of fixed dental restoration.
After a baseline phase of 1 month the mandible sides of subjects were randomly assigned to one of the 2 parallel treatment groups: one side received ANKYLOS plus implants. The contralateral sde recieved Certain PREVAIL Implants. Abutments were installed and loaded immediately by a fixed temporary bridge. After 3 months the final prosthesis was incorporated.
干预措施: Biomet 3i Prevail Implants (Device)
结局指标
主要结局
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
时间窗: 24 months after surgery
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
时间窗: 6 months after surgery
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
Effectiveness - Treatment Difference in Mean Change in Crestal Bone Level
时间窗: 12 months after surgery
Incidence of greater than 2 mm crestal bone (mesial or distal) loss. Reported in the percentage of analyzed implants.
次要结局
未报告次要终点