Guided Versus Conventional Graftless Lateral Sinus Lifting Using Peizo Electric Device in Patients With Atrophic Maxilla [a Randomized Controlled Clinical Trial]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- implant stability
研究概览
简要总结
Background: Dental implant therapy in the posterior maxilla may be difficult owing to limited bone height after dental extraction with sinus pneumatization. Several approaches for sinus floor elevation have been documented, and hence lateral sinus lifting using surgical guide is used.
Aim of the study: To compare between guided and conventional sinus lifting using piezoelectric device in patients with atrophic maxilla.
Methods: This study will be carried out as a randomized controlled clinical trial; patients will be randomly allocated into two groups: in the study group 15 patients will undergo lateral sinus lifting using surgical guide, while in the control group 15 patients will undergo conventional sinus lifting without surgical guide with simultaneous implant placement.
Clinical evaluation including intraoperative assessment of duration of surgery and immediate complications such as perforation of Schneiderian membrane, arterial laceration and trauma to adjacent roots and nasal bleeding. Primary implant stability will be measured immediately after implant placement
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient seeking replacement of a missed maxillary posterior tooth/ teeth by a delayed dental implant procedure
- •Residual bone height is 4-5 mm measured from crestal bone to sinus floor.
- •Both genders.
- •Good oral hygiene
排除标准
- •Recent radiation therapy in maxilla.
- •Uncontrolled systemic diseases such as diabetes mellitus.
- •Acute/chronic maxillary sinusitis.
- •Heavy smoker (those who smoke ≥ 25 cigarettes a day).
- •Alcohol abuse.
- •Psychosis.
- •Severe allergic rhinitis.
- •Tumor or large cyst in the maxillary sinus.
- •Oroantral fistula.
研究组 & 干预措施
Test Group
干预措施: lateral sinus lifting with guide (Procedure)
Control Group
干预措施: conventional lateral sinus lifting (Procedure)
结局指标
主要结局
implant stability
时间窗: 6 months
• Secondary implant stability will be measured 6 months post-operatively using Osstell device.
Post operative edema
时间窗: 1 week
it will be assessed in the 1st week as following: 1. None (no swelling) 2. Mild (intra oral swelling confined to surgical field) 3. Moderate (extra oral swelling in the surgical zone) 4. Severe (extra oral swelling spreading beyond the surgical zone)
change in pain scores
时间窗: up to 7 days
\- Post operative pain will be assessed through a 10 point visual analogue scale (VAS). (0-1=none, 2-4=mild, 5-7=moderate, 8-10=severe)
次要结局
未报告次要终点