An interventional study of Conventional Rotary Lateral Sinus Floor Elevation and Epinephrine-Soaked Cotton Roll in Posterior Maxillary Atrophy and Maxillary Sinus Augmentation, sponsored by Istanbul Aydın University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Istanbul Aydın University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Procedure: Conventional Rotary Lateral Sinus Floor Elevation
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.
Procedure: Epinephrine-Soaked Cotton Roll
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.
Procedure: Piezoelectric Sinus Lift
A lateral sinus window is created using a rotary round diamond bur. After removal of the bony window, the Schneiderian membrane is elevated using conventional manual sinus instruments. Membrane integrity is evaluated by direct visualization and the Valsalva maneuver. Subsequent grafting and implant-related procedures are performed according to the standardized study protocol.
Also known as: Standard Procedure, SP
A lateral sinus window is created 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 is placed over the exposed sinus membrane and bony window for 5 minutes to promote local hemostasis. After cottonoid removal, membrane elevation is continued using conventional manual sinus instruments. Subsequent procedures follow the standardized study protocol.
Also known as: Epinephrine-Soaked Cottonoid-Assisted Lateral Sinus Floor Elevation, ESCR
The lateral sinus window is created using US2 and UL4 piezoelectric surgical tips. The Schneiderian membrane is subsequently elevated using UL2 and UL5 piezoelectric inserts, supplemented with conventional manual sinus instruments when necessary. Membrane integrity is evaluated by direct visualization and the Valsalva maneuver. Subsequent grafting and implant-related procedures are performed according to the standardized study protocol.
Also known as: Piezoelectric Lateral Sinus Floor Elevation, PESL
Intraoperative bleeding score
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.
Time frame: Immediately after completion of surgery
Surgical Field Visibility Score
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.
Time frame: Immediately after completion of surgery
Procedural Simplicity Score
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.
Time frame: Immediately after completion of surgery
Operation time
Operation time is measured using a stopwatch and recorded in minutes, rounded to the nearest whole number. Higher values indicate a longer surgical procedure.
Time frame: From the start to the completion of sinus membrane elevation
Intraoperative Schneiderian Membrane Perforation
Schneiderian membrane perforation is assessed intraoperatively by direct visualization and the Valsalva maneuver and recorded as a binary outcome (yes/no). The outcome is reported as the number and percentage of participants experiencing membrane perforation in each intervention group.
Time frame: During the surgical procedure, through completion of sinus membrane elevation
Plan to share: No — Individual participant-level data will not be made publicly available because of participant confidentiality and institutional data-protection requirements. Aggregated data may be available from the corresponding author upon reasonable request, subject to ethical and institutional approval.
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Istanbul Aydın University