Implant Supported Single Crowns With Different Retention Modes - Effects on Peri-implant Tissue: A Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Change of matrix metalloproteinase 8 level
研究概览
简要总结
This study aims to examine the inflammatory response mediated by MMP-8 (Matrix metalloproteinase-8 ) level in peri-implant sulcus fluid adjacent to screw-retained, cemented or using the Acuris-system fixed single implant crowns as well as changing of the marginal bone level within the first year after implant restoration. Furthermore periodontal parameters, patient satisfaction and possible occurring biological or technical complications will be evaluated.
详细描述
After giving their written consent volunteers will be screened and eligible subjects will be randomized to three different groups. In group 1 Acuris® is used as fixation type; in group 2 screw retention, and in group 3 cementation is used. After 3 months of submerged healing the dental implants will be restored with all ceramic single implant crowns, fixed by using the randomized fixation mode. Follow-up visits till one year after implant restoration will be performed. At least 11 study visits during 16 months will be conducted.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •capability of giving an informed consent
- •good health as defined by the subjects medical history (no contraindications as described in the
排除标准
- •age 18 to 99 years
- •Good periodontal status: BOP < 20%, PI < 30%, no PD > 4mm
- •No heavy smokers (< 10 cigarettes/day)
- •at least 1 missing tooth in the premolar and molar region (with at least a mesial neighboring tooth/implant showing adequate hard- and soft tissue situation without the need of crestal hard- or soft tissue augmentation) either in the maxilla or in the mandible requiring implant therapy for reconstruction, requiring sinus floor augmentation or not.
- •Exclusion Criteria
- •Insufficient bone volume for implant placement requiring GBR (guided bone regeneration) procedure in crestal area.
- •Heavy Smokers (>10 cigarettes/day)
- •Medication with a contraindication for implant therapy (especially antiresorptive therapy, ongoing or recently completed local radiotherapy, systematic diseases, ongoing immunosuppressive therapy, functional disorders like Bruxism).
- •Skeletal immaturity.
- •Any active malignancy or ongoing treatment for malignancy.
- •An active infection (e.g. caries, gingivitis, periodontitis) at or in the neighboring area of the operative site.
- •Pregnancy
- •unable or unwilling to return for follow-up visits for a period of at least 16 months
研究组 & 干预措施
conometric concept (Acuris system)
single implant crown retention using friction only
干预措施: conometric concept Acuris system (Other)
screw retention
screw retained implant Crown fixation
干预措施: screw retention (Other)
cementation
cement retained implant Crown fixation
干预措施: cementation (Other)
结局指标
主要结局
Change of matrix metalloproteinase 8 level
时间窗: 4 months after implant placement, 3, 6 and 12 months after integration of the implant crown
biomarker for Inflammation of peri-implant disease; in ng/ml
Change of marginal bone level
时间窗: at baseline, 4 months after implant placement and 3, 6 and 12 months after restoration
assessed by single tooth x-ray; in mm
次要结局
- Number of occurrences of chipping(measured after integration of implant crown 3, 6 and 12 months after restoration)
- Bleeding on Probing (BOP)(at baseline, 4, 7, 10 and 16 months after implantation)
- Patient satisfaction concerning the implant crown(measured 12 months after restoration)
- Number of occurrences of fractures(measured after integration of implant crown 3, 6 and 12 months after restoration)
- Change of probing depth (PD)(at baseline, 4, 7, 10, 16 months after implantation)
- Number of occurrences of crown loosening(measured after integration of implant crown 3, 6 and 12 months after restoration)
- soft tissue maintenance(measured 4 months after implant placement and 3, 6 and 12 months after restoration)
- dentist satisfaction(measured 12 months after restoration)
- patient satisfaction(measured at baseline, 3 and 12 months after restoration)
- Plaque Index (PI)(at baseline, 4, 7, 10 and 16 months after implantation)
- technician satisfaction(measured 12 months after restoration)
- Number of occurrences of screw loosening(measured after integration of implant crown 3, 6 and 12 months after restoration)