Endoscopic Assessment of Schneiderian Membrane Perforation During Osseodensification-mediated Transcrestal Sinus Floor Elevation With Immediate Implant Placement in Subsinus Bone Height of 4-6 mm: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- incidence of Scheiderian membrane perforation
研究概览
简要总结
This present study will evaluate Schneiderian membrane perforation rates using osseodensification in TSFE with simultaneous graftless implant placement, under sinuscopic control monitored by an ENT specialist.
An endoscopic evaluation will be continuously conducted throughout the surgical procedure. TSFE will be performed using Densah burs without the addition of bone graft material, followed by implant placement. The rationale behind this approach is to monitor the response of the Schneiderian membrane and assess the effects of Densah burs on membrane distention and the occurrence of SMP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •males and females over 21 years of age;
- •partial edentulism in the posterior maxilla involving 2 or more adjacent teeth in the premolar-molar area;
- •teeth at the intended implant sites must have been extracted or lost at least 9 months before the date of implant surgery;
- •sinus floor with a relatively flat contour confirmed on baseline CBCT;
- •bucco-palatal sinus width (distance between the buccal and palatal walls at 10-mm apical level comprising the residual alveolar crest ) 8-12 mm confirmed on baseline CBCT to minimize the risk of SMP during surgery (Stacchi et al. 2022);
- •sinus membrane thickness ≤ 2 mm;
- •subsinus residual bone height (RBH) 4-6 mm at the intended implant sites and bucco-palatal bone width allowing implant placement without bone augmentation procedures.
排除标准
- •systemic conditions contraindicating implant surgery;
- •pregnancy or lactation;
- •ongoing or history of pathologies or medications affecting bone metabolism;
- •ongoing or history of head and neck irradiation;
- •oral inflammatory and autoimmune diseases;
- •presence of osseous lesions or persistent infections in the planned implant sites;
- •previous bone augmentation surgery;
- •uncontrolled periodontal diseases;
- •heavy smoking (> 10 cigarettes/day);
- •history of sinus surgery;
- •presence of intrasinus bony septa that could affect membrane elevation and distention; and
- •ongoing or history of rhinitis or sinusitis.
研究组 & 干预措施
SMP
干预措施: Scheiderian Membrane Perforation (Device)
结局指标
主要结局
incidence of Scheiderian membrane perforation
时间窗: Perioperative
The primary aim of the present clinical study is to evaluate the incidence of SMP during TSFE with immediate implant placement performed by a trainee surgeon using the osseodensification technique under sinuscopic control in sinuses of comparable contour
次要结局
- primary stability achieved by the implants at insertion measured with the insertion torque value, in N.cm(Perioperative)
- qualitative pattern of membrane distention, differentiated into either a U-shaped dome or a V-shaped dome(Perioperative)
- time at which the potential perforation occur(Perioperative)
- Size of potential perforations, in mm, classified as pinhole <1mm, small >1mm and <2mm, medium >2mm and < 3mm, large >3mm(Perioperative)