Comparison of Intraoperative Conditions and Schneiderian Membrane Perforation Risk Among Three Surgical Approaches for Lateral Sinus Floor Elevation: A Prospective Comparative Study
Sponsor study identifier
interventional
504
1 country
1
Study Start
May 1, 2021
Actual (reported)Primary Completion
July 24, 2026
Actual (reported)Study Completion
July 24, 2026
Actual (reported)This study compares three surgical approaches used during lateral sinus floor elevation, a procedure performed to increase bone height in the back part of the upper jaw before or together with dental implant placement. Participants are randomly assigned to one of three groups: a standard surgical procedure, a technique using an epinephrine-soaked cotton roll to help control bleeding, or a piezoelectric surgical technique. The study compares these approaches in terms of bleeding during surgery, visibility of the surgical field, ease of performing the procedure, operation time, and Schneiderian membrane perforation, an intraoperative complication that can occur during sinus lift surgery. Patient-related and anatomical factors, including age, sex, smoking status, residual bone height, sinus membrane thickness, lateral sinus wall thickness, and the presence of sinus septa, are also recorded. The aim is to determine whether the surgical approach influences intraoperative conditions and membrane perforation and whether patient-related or anatomical factors are associated with these outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 24, 2026
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2021
Actual (reported)July 24, 2026
Actual (reported)July 24, 2026
Actual (reported)August 26, 2026
Actual (reported)August 31, 2026
Actual (reported)Intraoperative bleeding score
Intraoperative bleeding was assessed immediately after surgery by the operating surgeon using an 11-point numerical rating scale (NRS; 0-10). A score of 0 indicated no bleeding, whereas a score of 10 indicated excessive bleeding sufficient to compromise the surgical field. Higher scores represented greater intraoperative bleeding.
Immediately after completion of surgery
Surgical Field Visibility Score
Surgical field visibility was assessed immediately after surgery by the operating surgeon using an 11-point numerical rating scale (NRS; 0-10). A score of 0 indicated the poorest possible surgical visibility, whereas a score of 10 indicated optimal visibility. Higher scores represented better surgical field visibility.
Immediately after completion of surgery
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.
The lateral sinus window was prepared using a rotary round diamond bur. Following completion of the lateral sinus wall osteotomy, a cottonoid was saturated with an additional 1 mL of Ultracain D-S Forte, containing 40 mg articaine hydrochloride and 0.012 mg epinephrine, and applied to the surgical field for 5 minutes. After removal of the cottonoid, Schneiderian membrane elevation was continued using conventional manual sinus instruments.
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.
Istanbul Aydin University
Istanbul, 34295, Turkey (Türkiye)
Mehmet Kagan Degerliyurt, DDS, PhD
Istanbul Aydın University
504 participants (actual enrollment reported by the registry).
First Submitted
Maxillary Sinus Lift With and Without Self-hardening Biphasic Calcium Phosphate.
Procedural Simplicity Score
Procedural simplicity was assessed immediately after surgery by the operating surgeon using an 11-point numerical rating scale (NRS; 0-10). A score of 0 indicated maximal procedural difficulty, whereas a score of 10 indicated the greatest ease of surgical handling. Higher scores represented greater procedural simplicity.
Immediately after completion of surgery
Operation time
Operation time was measured using a stopwatch from initiation of the lateral-window osteotomy to completion of Schneiderian membrane elevation and was recorded in minutes, rounded to the nearest whole number. Graft placement and implant placement were not included in the recorded operation time. Higher values indicated a longer operative duration.
From the start to the completion of sinus membrane elevation
Intraoperative Schneiderian Membrane Perforation
During the surgical procedure, through completion of sinus membrane elevation
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.
A lateral sinus window is created using a rotary round diamond bur. Following completion of the lateral sinus wall osteotomy, a cottonoid saturated with an additional 1 mL of Ultracain D-S Forte, containing 40 mg articaine hydrochloride and 0.012 mg epinephrine, is applied to the surgical field for 5 minutes to promote local hemostasis. After removal of the cottonoid, Schneiderian membrane elevation is continued using conventional manual sinus instruments. Subsequent procedures follow the standardized study protocol.
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.
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August 26, 2026
First Posted
August 31, 2026
Study Start
May 1, 2021
Actual (reported)Primary Completion
July 24, 2026
Actual (reported)Study Completion
July 24, 2026
Actual (reported)Last Updated
October 7, 2026
Record last verified: 2026-10
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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