Patient Satisfaction and Clinical Outcomes Following Mandibular Single-implant-retained Overdenture Treatment in Residents of Nursing Homes: a Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Patient satisfaction after insertion of the new complete dentures.
研究概览
简要总结
Study hypothesis: that there would be no difference in patient satisfaction among institutionalised older people before and after treatment with a mandibular single implant-retained overdenture.
In a preliminary phase, a new denture is made or the old denture is adapted to provide a well-fitting denture.
Eight weeks after insertion of the new denture a single implant is placed in the centre of the mandibula. If the level of primary stability is sufficient to enable the implant to resist micromovement, the implant is immediately loaded . If not, the implant is loaded after 6 to 12 weeks. Primary stability is assessed by the final seating torque and by the clinician's interpretation and tactile sense of primary stability. Before, during and after the treatment patient satisfaction and clinical outcomes are evaluated by a 20 item questionnaire and a clinical examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Edentulous residents of nursing homes treated in the mobile dental unit 'Gerodent'.
- •They have to be willing to commit to 1.5 year of participation in the study.
- •They have to be edentulous for at least one year before starting the implant procedure.
排除标准
- •Medical conditions contraindicating implant surgery (unregulated diabetes type II, bisphosphonates)
- •History of radiotherapy in the head and neck region
- •Insufficient bone for an implant of at least 10 mm length and 4 mm diameter
- •Previously treated with dental implants
结局指标
主要结局
Patient satisfaction after insertion of the new complete dentures.
时间窗: 1 week after insertion of the new complete dentures.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading.
时间窗: 1 year after loading
This will be measured by a questionnaire with 20 items.
Patient satisfaction post-surgical.
时间窗: 1 week post-surgical.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after loading the implant.
时间窗: 1 week after loading the implant.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after insertion of the complete dentures.
时间窗: 8 weeks after insertion of the complete dentures.
This will be measured by a questionnaire with 20 items.
Patient satisfaction after surgical procedure, functional loading.
时间窗: 6-8 weeks after surgical procedure.
This will be measured by a questionnaire with 20 items.
次要结局
- Repair management: type (fracture, matrix replacement, patrix activation, mechanical problems of the abutment, replacement of denture, relining, adjustment without adding new material) and number.(From 8 weeks after insertion of the complete dentures to 6 months after loading.)
- Maintenance - oral hygiene: Implant abutment: plaque index according to Mombelli, presence of calculus.(From 1 week after loading the implant to 6 months after loading.)
- Denture related: soft tissue problems.(From 1 week after insertion of the new complete dentures to 6 months after loading.)
- Maintenance - oral hygiene: Dentures using the denture plaque index by Augsburger and Elahi.(From 8 weeks after insertion of the complete dentures to 6 months after loading.)
- Implant level : lost implants, loose implants, …(From the first week post-surgical to 1 year after loading.)
- Soft tissue level : Peri-implant inflammation, bleeding index, probing depth(From the first week post-surgical to 1 year after loading.)