Comparison of Intraoperative Conditions and Schneiderian Membrane Perforation Risk Among Three Surgical Approaches for Lateral Sinus Floor Elevation: A Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- Intraoperative bleeding score
研究概览
简要总结
This prospective comparative clinical study evaluates three surgical approaches used for lateral sinus floor elevation: the standard rotary technique, an epinephrine-soaked cotton roll assisted technique, and a piezoelectric technique. The study compares intraoperative bleeding, surgical field visibility, procedural simplicity, operation time, and the occurrence of Schneiderian membrane perforation. It also examines whether patient and anatomy related factors, including smoking, residual bone height, sinus membrane thickness, and sinus septa, are associated with membrane perforation. The aim is to determine which factors contribute most strongly to surgical conditions and perforation risk during lateral sinus floor elevation.
详细描述
This single center prospective comparative clinical study evaluates intraoperative conditions and Schneiderian membrane perforation during lateral sinus floor elevation performed using three surgical approaches. Eligible patients requiring lateral sinus floor elevation for implant rehabilitation are allocated sequentially according to a predefined alternating sequence to the standard procedure (SP), epinephrine-soaked cotton roll assisted procedure (ESCR), or piezoelectric sinus lift (PESL) group.
In the SP group, the lateral window is prepared using conventional rotary instrumentation, and the Schneiderian membrane is elevated using manual sinus instruments. In the ESCR group, after lateral window preparation and initial membrane elevation, a cotton roll soaked with 4% articaine containing 1:100,000 epinephrine is applied to the sinus membrane and lateral window region for approximately 5 minutes before membrane elevation is continued. In the PESL group, piezoelectric instruments are used for lateral window preparation and membrane elevation. Subsequent grafting and implant-related procedures are performed according to the same standard surgical protocol in all groups.
Patient related and anatomical variables, including age, smoking status, side of surgery, residual bone height, Schneiderian membrane thickness, and the presence of sinus septa, are recorded preoperatively. Anatomical measurements are obtained from cone-beam computed tomography images. Intraoperative bleeding, surgical field visibility, and procedural simplicity are assessed using 0-10 visual analogue scales. Operation time is recorded using a stopwatch, and Schneiderian membrane perforation is documented as a binary outcome.
The primary objective is to compare intraoperative conditions and membrane perforation among the three surgical approaches. The secondary objective is to determine whether patient-related, anatomical, and intraoperative factors are associated with membrane perforation. Statistical analyses include between-group comparisons, correlation analyses, and multivariable logistic regression models.
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
Due to the inherent differences among the surgical interventions, masking of the operating surgeon and intraoperative outcome assessment was not feasible. Data organization and statistical analyses were performed by an independent evaluator who was blinded to treatment allocation.
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
- •Must be older than 18 years
- •Clinical diagnosis of absence of one or more maxillary posterior molars with a healing period of at least 6 months after extraction
- •Clinical indication for Lateral Sinus Floor Elevation with either simultaneous or delayed implant placement; residual bone height ≤5 mm at the planned implant site
- •Must be confirmed by cone-beam computed tomography (CBCT)
- •Must have an availability of complete medical, clinical, and radiographic records.
排除标准
- •Pathological sinus mucosal thickening or other radiographic or clinical evidence of sinus disease
- •Untreated periapical or periodontal infection adjacent to the maxillary sinus
- •Current or previous exposure to antiresorptive agents (e.g., bisphosphonates or denosumab) or antiangiogenic medication
- •History of head and neck radiotherapy
- •Requirement for additional vertical or horizontal bone augmentation procedures other than LSFE
- •Previous LSFE involving the same maxillary sinus.
研究组 & 干预措施
Epinephrine-Soaked Cotton Roll (ESCR)
The lateral sinus window was prepared using a rotary round diamond bur. Following initial reflection of the Schneiderian membrane, a cottonoid soaked with one carpule of 4% articaine containing 1:100,000 epinephrine was placed over the exposed sinus membrane and bony window for 5 minutes. After removal of the cottonoid, membrane elevation was continued using conventional manual sinus instruments.
干预措施: Epinephrine-Soaked Cotton Roll (Procedure)
Piezoelectric Sinus Lift (PESL)
The lateral sinus window was prepared using US2 and UL4 piezoelectric surgical tips. The Schneiderian membrane was elevated using UL2 and UL5 piezoelectric inserts, supplemented with conventional manual sinus instruments when necessary.
干预措施: Piezoelectric Sinus Lift (Procedure)
Conventional Rotary Lateral Sinus Floor Elevation (SP)
The lateral sinus window was prepared using a rotary round diamond bur. After removal of the bony window, the Schneiderian membrane was elevated using conventional manual sinus instruments.
干预措施: Conventional Rotary Lateral Sinus Floor Elevation (Procedure)
结局指标
主要结局
Intraoperative bleeding score
时间窗: Immediately after completion of surgery
Intraoperative bleeding is assessed immediately after surgery by the operating surgeon using a 0-10 visual analog scale. A score of 0 indicates no bleeding, and a score of 10 indicates excessive bleeding sufficient to compromise the surgical field. Higher scores indicate greater intraoperative bleeding.
Surgical Field Visibility Score
时间窗: Immediately after completion of surgery
Surgical field visibility is assessed immediately after surgery by the operating surgeon using a 0-10 visual analog scale. A score of 0 indicates the poorest possible surgical visibility, and a score of 10 indicates optimal visibility. Higher scores indicate better surgical field visibility.
Procedural Simplicity Score
时间窗: Immediately after completion of surgery
Procedural simplicity is assessed immediately after surgery by the operating surgeon using a 0-10 visual analog scale. A score of 0 indicates maximal procedural difficulty, and a score of 10 indicates the greatest ease of surgical handling. Higher scores indicate greater procedural simplicity.
Operation time
时间窗: From the start to the completion of sinus membrane elevation
Operation time is measured using a stopwatch and recorded in minutes, rounded to the nearest whole number. Higher values indicate a longer surgical procedure.
次要结局
- Intraoperative Schneiderian Membrane Perforation(During the surgical procedure, through completion of sinus membrane elevation)
研究者
Mehmet Kagan Degerliyurt
Professor of Oral and Maxillofacial Surgery
Istanbul Aydın University