Evaluation of Simultaneous Implant Placement and Maxillary Sinus Floor Elevation With Gelatin Sponge Versus Allogenic Demineralized Bone Matrix: (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Stability
研究概览
简要总结
The post-extraction pneumatization of the maxillary sinus often compromises the ability of the maxillary molar to the optimal recipient of dental implants as a consequence of the quantitative reduction of the vertical bone height and the reduced bone quality of the region posterior maxillary segment.
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
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes, with an age range of (25 to 55 years) with unilateral or bilateral edentulous posterior maxillary molar region with \ vertical residual bone height of (four to six millimeters), a minimal horizontal bone width of six millimeters bone width, acceptable interarch space, and fair inter-jaw anteroposterior, horizontal and vertical relationships.
- •Proper general health and oral hygiene.
排除标准
- •The presence of sinusitis, local sinus pathosis, or a systemic disease that would affect the final treatment outcomes, bone remodeling process, or maxillary sinus health.
- •Those patients with a history of previous bone graft, sinus lift, or failed implant.
研究组 & 干预措施
Test group: Gelatin Sponge
The surgical intervention will be executed under local anesthesia. After the elevation of the full-thickness mucoperiosteal flap over the lateral wall of the maxillary sinus, a circular lateral window will be created by sinus low-speed bur grinding of the cortical ring to guard against the Shniederian membrane violation, followed by its separation along the sinus floor, lateral walls and the boundaries of the window to elaborate a smooth superior membrane elevation.
The created spaces beneath the elevated Shniederian membrane will be filled up by an absorbable gelatin sponge for the test group patients followed by the coverage of the side window with collagen membrane, secured with bone tacks to guard against the graft fibroblastic invasion.
干预措施: Sinus lifting (Procedure)
Control group: Allogenic Demineralized Bone Matrix
The surgical intervention will be executed under local anesthesia. After the elevation of the full-thickness mucoperiosteal flap over the lateral wall of the maxillary sinus, a circular lateral window will be created by sinus low-speed bur grinding of the cortical ring to guard against the Shniederian membrane violation, followed by its separation along the sinus floor, lateral walls and the boundaries of the window to elaborate a smooth superior membrane elevation.
The created spaces beneath the elevated Shniederian membrane will be filled up by allogenic (DBM) for the control group patients, followed by the coverage of the side window with collagen membrane, secured with bone tacks to guard against the graft fibroblastic invasion.
干预措施: Sinus lifting (Procedure)
结局指标
主要结局
Stability
时间窗: 6 months
Aided by the Osstell device, the authors will record the (ISQ) readings at implant placement and upon its exposure for prosthetic rehabilitation after six months as a secondary outcome. The mean (ISQ) of the maxillary sinus lift procedure would employ the mean of parallel and perpendicular (ISQ) readings to each implant long axis where one implant is inserted and the mean of the two implant readings when two implants are placed. The numerical data concerning the primary and secondary outcomes will be recorded, scheduled, and submitted for statistical analysis
Vertical bone gain
时间窗: 6 months
baseline and final outcome for measuring both groups' radiographic vertical bone height gain as a primary outcome aided by the (Blue-sky software) identification of four reference points along each implant buccal, palatal, mesial, and distal surface
Stability
时间窗: 6 months
Aided by the Osstell device, the authors will record the (ISQ) readings at implant placement and upon its exposure for prosthetic rehabilitation after six months as a secondary outcome. The mean (ISQ) of the maxillary sinus lift procedure would employ the mean of parallel and perpendicular (ISQ) readings to each implant long axis where one implant is inserted and the mean of the two implant readings when two implants are placed. The numerical data concerning the primary and secondary outcomes will be recorded, scheduled, and submitted for statistical analysis
次要结局
未报告次要终点
研究者
Ahmed Nagi Alghandour
Lecturer
Beni-Suef University