NCT06050213Enrolling By Invitation不适用
Maxillary Overdenture Retained by Different Number of Implants Opposed by 2-implant Assisted Mandibular Overdenture. A Cross-over Study of Patient Satisfaction
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
This within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •o Healthy and free from any systemic diseases that may interfere with the osseointegration of implants.
- •Patients have completely edentulous maxilla for at least 6 months after last extraction with opposing mandibular two-implant Overdentures.
- •The patients have angle class I maxillomandibular skeletal relation and sufficient interarch space not less than (10-12 mm) as detected by tentative jaw relation.
- •Maxillary and mandibular alveolar ridges covered with healthy, firm, relatively even thickness and even compressible mucosa as detected by palpation with the blunt end of the mirror and free from any signs of inflammation or flabbiness as detected by clinical examination.
- •Good quality and quantity of maxillary residual alveolar ridge, as detected by CBCT, available for implant width (3.7mm, 5mm for anterior and posterior implants respectively) and length (12mm, 10mm for anterior and posterior implants respectively) this was ascertained by CBCT.
排除标准
- •o Any history of metabolic or systemic diseases that may affect integration of implant or connective tissue health surrounding implant.
- •History of irradiation in head-and-neck area.
- •Heavy smokers (more than 10 cigarettes per day)
- •Parafunctional habits such as bruxism.
- •Psychiatric disorders or unrealistic expectations.
- •Positive pregnancy test up to 5 days before surgery.
- •Severe thrombocytopenia and bleeding disorders.
- •Pathologic condition of soft tissue (bacterial and viral stomatitis, hyperplasia, cyst, fibrous lesions)
- •Patients with local contraindications for implant placement due to localized bone defects and poor bone quality (D5).
- •Patients with TMJ disorders or poor neuromuscular coordination.
结局指标
主要结局
Patient satisfaction
时间窗: one year
patient satisfaction will be evaluated for all patients by a questionnaire using visual analogue scale
Bite force
时间窗: one year
Bite force will be evaluated for all patients by a digital bite force device
次要结局
未报告次要终点
研究者
研究点 (2)
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