NCT01899131Unknown不适用
A Prospective Clinical and Radiographic Assessment on New Platform-switched Laser Lok Implants
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- epithelial attachment and bone level around implants
研究概览
简要总结
- To investigate the hard and soft tissue adaptation and maintenance to the Laser-Lok® microchannels permanent abutment/ new Laser-Lok® implant assembly by performing clinical and radiographic evaluations.
- To investigate the effect of inter-implant spacing (minimum of 2 or 3 mm) on hard and soft tissues.
- To perform clinical and radiographic evaluations on these abutment/implant assemblies up to 2 years.
详细描述
- Screening (Inclusion/ Exclusion Criteria)
- Day of Surgery: Dental CT scan/ periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
- Implant Restoration Day: Post-restoration periapical radiograph/ clinical picture/ clinical examination (probing depth, BOP, gingival recession).
- 6 month, 1 Year and 2 Year Post Restoration: periapical radiograph / clinical picture / clinical examination (probing depth, BOP, gingival recession).
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, between 20-70 years of age, who request dental implant treatment options for rehabilitation.
- •Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
- •Subjects without significant medical history and currently not on medications that might complicate the results.
- •Subjects presenting with an edentulous area requiring a tooth-replacement option.
排除标准
- •Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
- •Subjects who received and failed a previously placed dental implant.
- •Subjects who require an onlay ridge augmentation procedure in the area to achieve adequate bone volume for the placement of dental implants.
- •Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
- •Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
- •Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%.
- •Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
- •Subjects who are nursing or pregnant.
- •Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
- •Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
- •Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
- •Acutely infected defect site.
- •Immediate implant site.
结局指标
主要结局
epithelial attachment and bone level around implants
时间窗: 2 years
prevent apical migration of the epithelial attachment, and preserve bone level around implant head. radiographic and clinical assessment during recall periods
次要结局
- inhibit the loss of crestal bone .(2 years)
研究者
研究点 (2)
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