"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Pain and discomfort on VAS scale at the 4th postoperative day
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of the lateral sinus lift procedure using the tunnel technique flap in comparison to the traditional lateral sinus lift in partially or totally edentulous patients with loss of teeth in the maxillary premolar or molar areas and severe alveolar atrophy. The primary questions it aims to answer are:
- Is the tunnel flap technique more suitable for lateral sinus lift than the trapezoidal flap technique in terms of post-operative symptoms?
- Is the tunnel technique safer and more effective than the trapezoidal flap technique in terms of complication rate and the effectiveness of bone grafting?
Participants will undergo the lateral sinus lift procedure using the tunnel technique, which involves making a vertical anterior incision. Patients will receive follow-up care, including phone contact the day after the procedure to detect any issues, and they will keep a diary during the week after surgery to record visual analog scale (VAS) pain values and analgesics taken. Follow-up surgical visits will be scheduled for suture removal and at 30 days after suture removal. After 6 months, dental implants will be inserted, and prosthetic rehabilitation will take place 6 months later. Implants will be monitored for up to 12 months after prosthetic rehabilitation.
Researchers will compare the outcomes of tunnel flap technique lateral sinus lift with the trapezoidal flap sinus lift.
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
盲法说明
Health care givers, investigators and outcome assessors cannot be masked to treatment allocation due to the characteristics of the intervention. The statistician will be masked to the treatment allocation during data analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •edentulous or partly edentulous patients with a unilateral loss of teeth in the maxillary premolar or molar areas
- •severe alveolar atrophy and a residual severe alveolar ridge height up to 3 mm
排除标准
- •severe illness
- •head and neck radiation therapy
- •chemotherapy
- •antiresorptive therapy
- •uncontrolled diabetes
- •uncontrolled periodontal disease
- •smoking >10 cigarettes per day
- •facial or neck inflammatory or oncologic diseases
- •obliteration of sinus ostium and osteomeatal complex
结局指标
主要结局
Pain and discomfort on VAS scale at the 4th postoperative day
时间窗: First week after sinus lift procedure
Participants will record the subjective post-operative pain/discomfort on a daily VAS score (0 to 10) for the first 7 days, at the same time each day, on a specific form. The VAS is a horizontal ruler 10 cm long with the left end (0 cm) indicating "no pain/discomfort at all" and the right limit (10 cm) indicating "the worst pain imaginable. Patients will be also asked to record the need for analgesics (including type and quantity).
次要结局
- Times for surgical procedure(During sinus lift procedure)
- Soft tissue healing after sinus lift(10 days and 40 days after sinus lift procedure)
- Sinus lift related complications(During sinus lift procedure, 1, 10 and 40 days from procedure.)
- Graft healing after a 6 months period(6 months after implant procedure)