NCT04838184Unknown不适用
Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Survival
研究概览
简要总结
Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.
详细描述
It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length in the same clinical situation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •General criteria:
- •Age: 18 to 70
- •Edentulous mandible with reduced bone level in the posterior region (> 5 mm and < 8 mm above nerve conduit)
- •Physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems
- •Obtained informed consent from the patient
- •Specific criteria:
- •Limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used
- •Tooth loss or extraction at least 8 weeks before implant surgery
- •Healthy implantation site
- •Favorable and stable occlusal relationship
- •Complete denture in the mandible. If no denture available, an interims prosthesis will be fitted
- •Natural full dentition or sufficient complete or partial dentures in the maxilla
排除标准
- •General criteria:
- •Any conditions or circumstances which would interfere with the requirements for oral surgery
- •Allergy to any metallic implant component
- •Acute, untreated periodontitis
- •Previous oro-maxillo-facial radiotherapy
- •Any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease)
- •Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.)
- •Alcohol or drug abuse
- •Heavy smoking (>10 cigarettes/day)
- •Uncontrolled diabetes
- •Severe bruxism or other destructive oral habits
- •Pregnant or lactating women
- •Specific criteria:
- •Need for a major bone regeneration technique
- •Infections in adjacent tissue of the planned implantation site.
- •Bleeding on probing (BOP) and plaque index (PI) higher 25%
- •Insufficient bone volume in the posterior region for placing a Straumann Roxolid® / SLActive® 4mm short implant and in the interforaminal region for placing a Straumann Roxolid® / SLActive® implant with a minimum length of 10 mm determined by radiographic analysis (OPG)
结局指标
主要结局
Survival
时间窗: 5 years
Survival of implants and suprastructure. Measure: survival rates
次要结局
- Implant stability(3 months)
- Patient satisfaction(5 years)
- Success(5 years)
- Oral health-related quality of life(5 years)
研究者
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