NCT02158377已完成不适用
A Randomized Controlled Multicenter Study of Trabecular Metal Dental Implants vs.Tapered Screw-Vent Dental Implants Loaded Early vs. Conventionally in the Maxilla and Mandible.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ZimVie
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Implant Stability
研究概览
简要总结
Randomized-controlled, multicenter study of Trabecular Metal (TM) and Tapered Screw-Vent (TSV) dental implants loaded early in maxillary and mandibular sites.
详细描述
This is a randomized, controlled, multicenter study to assess and compare implant stability of Trabecular Metal (TM) dental implants and Tapered Screw-Vent (TSV) implants during the early stages of healing i.e. 21 +/- 2 days and 42+/- 2 days, as well as their short term clinical outcomes.
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
- 是
入选标准
- •Benefit from the implant and restoration
- •Provide a voluntarily signed Informed Consent
- •Must be 18 years or older
- •Have one or more edentulous area(s) in the posterior maxilla or mandible designated for an implant supported restoration
- •The implantation site must have a functional antagonist to obtain full occlusion.
- •Implants adjacent to planned site of implantation should have been in function for at least 1 year.
- •The site intended for implant placement should have healed for at least 4 months from the time of extraction or at least 6 months from any other bone augmentation procedures.
- •The site intended for implant placement should have adequate bone volume to support an implant without the need for augmentation except for minor dehiscence (limited to a vertical height of 2mm), which can be augmented with autogenous bone chips to improve soft tissue attachment.
- •The site intended for implant placement should have residual facial and palatal/lingual plates to be at least 1.0mm thick after implant placement.
- •The site intended for implant placement should have vertical bone volume to extend at least 2.0mm apical to the implant after implant placement.
排除标准
- •Subjects mentally incompetent or unable to understand and provide an Informed Consent
- •Smokers, alcoholics or drug abusers
- •Subjects with systemic conditions such as uncontrolled diabetes, endocrine disorders, heart disease, immune-compromised subjects or mental disorders
- •Use of concurrent medication which inhibits bone metabolism like bisphosphonates, corticosteroids or methotrexate
- •Bleeding disorders and/or anticoagulant therapy
- •Known sensitivity or allergy to any of the implant materials
- •Subjects with bruxism or clenching habits
- •Uncontrolled periodontal or oral pathologies (e.g. mucosal disease, oral lesions)
- •Inadequate oral hygiene
- •History of radiation at the site intended for study implant placement
- •Subjects who have previously failed dental implants at the site intended for study implant placement
- •Subjects participating in another clinical study
- •Subjects who need other surgeries in a site adjacent to the study implant(s)
- •Subjects who need other surgeries in a site non-adjacent to the study implant(s) within 6 months of study implant placement
研究组 & 干预措施
Tapered Screw-vent implants (TSV)
Active Comparator
TSV implants to replace missing tooth/teeth
干预措施: Tapered screw-vent implants (TSV) (Device)
Trabecular Metal dental implants (TM)
Experimental
TM dental implants to replace missing tooth/teeth
干预措施: Trabecular metal dental implants (TM) (Device)
结局指标
主要结局
Implant Stability
时间窗: 3-18 weeks
Measure of Implant Stability Quotient immediately post implantation
次要结局
- Marginal bone level change(2 years)
研究者
研究点 (3)
Loading locations...
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