Evaluation of the Hydrodynamic Piezoelectric Technique in Internal Sinus Lift With Simultaneous Implant Placement (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- change in implant stability
研究概览
简要总结
Background: The use of hydrodynamic piezoelectric techniques for trans crestal / internal sinus lift with simultaneous implant placement has gained popularity as a safe and minimally invasive technique for managing the posterior edentulous maxilla, particularly in cases with sinus pneumatization. This method offers a controlled elevation of the Schneiderian membrane while reducing the risk of perforation compared to conventional techniques. Additionally, it minimizes postoperative discomfort and oedema, leading to better acceptance and satisfaction by the patients. In contrast to traditional osteotome tapping procedures, the hydrodynamic piezoelectric technique enhances surgical outcomes while preserving vital anatomical structures, making it a superior alternative in implant dentistry. This study aims to evaluate the use of the hydrodynamic piezoelectric technique in internal sinus lifting with simultaneous implant placement in comparison to the conventional osteotome technique.
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
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with edentulous free end or bounded posterior maxilla that require implant supported restoration.
- •Patients indicated to internal sinus lifting, where insufficient residual alveolar bone height from the alveolar crest to the floor of the maxillary sinus is found.
- •Patients with residual alveolar bone height that ranges from 5-7 mm according to the tomographic radiographic examination.
- •A good standard of oral hygiene.
排除标准
- •Patients with residual alveolar bone height less than 5 mm according to the tomographic radiographic examination.
- •Patients with residual alveolar bone height more than 8 mm according to the tomographic radiographic examination, which is not indicated to sinus lifting.
- •Patient with active sinus infection or sinus pathology.
- •History of Oral or intravenous bisphosphonate therapy or any treatments with other medications that may interfere with bone metabolism within the past 12 months.
- •Heavy smokers.
- •Medically compromised patients that are burdened with systemic conditions that contradicts implant placement and interfere with wound healing.
- •Exclusion Criteria:
结局指标
主要结局
change in implant stability
时间窗: baseline and 6 months
Implant Stability Quotient (ISQ) will be measured during the operative stage, while the secondary stability quotient will be measured 6-months post-operative during the prosthetic phase preparation using Ostell device.
Change in wound healing
时间窗: at 7, 14, and 21 days
The wound healing will be assessed based on the Modified Healing Index. The Wound Healing Index (WHI) evaluates preimplant soft tissue wound healing with scores from 1 to 3. On this scale, a score of 1 indicates ordinary healing with the absence of gingival edema, erythema, suppuration, patient discomfort, and flap dehiscence. A score of 2 indicates ordinary healing with slight gingival edema, erythema, patient discomfort, and flap dehiscence, but no suppuration and a score of 3 corresponds to poor wound healing with significant gingival edema, erythema, patient discomfort, suppuration, and flap dehiscence, or any suppuration
Change in pain scores
时间窗: at 7, 14, and 21 days
Pain will be evaluated, using visual analogue scale (VAS) as follows: (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe).
Change in wound healing
时间窗: at 7, 14, and 21 days
The wound healing will be assessed based on the Modified Healing Index. The Wound Healing Index (WHI) evaluates preimplant soft tissue wound healing with scores from 1 to 3. On this scale, a score of 1 indicates ordinary healing with the absence of gingival edema, erythema, suppuration, patient discomfort, and flap dehiscence. A score of 2 indicates ordinary healing with slight gingival edema, erythema, patient discomfort, and flap dehiscence, but no suppuration and a score of 3 corresponds to poor wound healing with significant gingival edema, erythema, patient discomfort, suppuration, and flap dehiscence, or any suppuration
change in implant stability
时间窗: baseline and 6 months
Implant Stability Quotient (ISQ) will be measured during the operative stage, while the secondary stability quotient will be measured 6-months post-operative during the prosthetic phase preparation using Ostell device.
次要结局
- Change in Alveolar Process height gain(baseline and 6 months)
- Change in Alveolar Process height gain(baseline and 6 months)
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University