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 2026-10-07.
Sponsored by Istanbul Aydın University · Not applicable, Interventional, and Treatment
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.
This single-center, prospective, randomized, three-arm clinical trial evaluated intraoperative conditions and Schneiderian membrane perforation during lateral sinus floor elevation (LSFE) performed using three surgical approaches. Eligible patients requiring LSFE for implant rehabilitation were randomized in a 1:1:1 ratio to the standard procedure (SP), epinephrine-soaked cotton roll technique (ESCR), or piezoelectric sinus lift (PESL) group. The randomization sequence was computer-generated by an independent statistician using variable permuted blocks of 6, 9, and 12 participants. Treatment allocation was concealed through a centralized electronic allocation system and was released only after eligibility had been confirmed and written informed consent had been obtained.
A standardized local anesthesia protocol was used in all three groups. Before incision, 3 mL of Ultracain D-S Forte, corresponding to 120 mg articaine hydrochloride and 0.036 mg epinephrine, was administered. In the SP group, the lateral window was prepared using conventional rotary instrumentation, and the Schneiderian membrane was elevated using conventional hand instruments. In the ESCR group, 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, was applied to the surgical field for 5 minutes. After removal of the cottonoid, membrane elevation was continued using conventional hand instruments. In the PESL group, piezoelectric instruments were used for lateral-window preparation and membrane elevation, with conventional hand instruments used when required to complete membrane elevation. Subsequent grafting and implant-related procedures were performed according to standardized surgical protocols.
Patient-related and anatomical variables, including age, sex, smoking status, side of surgery, residual bone height (RBH), Schneiderian membrane thickness, lateral wall thickness (LWT), and the presence of maxillary sinus septa, were recorded preoperatively. Anatomical measurements were obtained from cone-beam computed tomography (CBCT) images. Schneiderian membrane perforation was assessed intraoperatively and recorded as a binary outcome (yes/no).
The four co-primary intraoperative outcomes were bleeding, surgical field visibility, procedural simplicity, and operation time. Bleeding, visibility, and procedural simplicity were assessed immediately after completion of surgery by the operating surgeon using 11-point numerical rating scales (NRSs; 0-10). For bleeding, 0 indicated no bleeding and 10 indicated excessive bleeding sufficient to compromise the surgical field. For visibility, 0 indicated the poorest possible surgical visibility and 10 indicated optimal visibility. For procedural simplicity, 0 indicated maximal procedural difficulty and 10 indicated the greatest ease of surgical handling. 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.
The primary objective was to compare the three surgical techniques with respect to the four co-primary intraoperative outcomes. Schneiderian membrane perforation constituted the principal secondary outcome. Additional secondary analyses evaluated whether the associations between intraoperative bleeding, visibility, and procedural simplicity and membrane perforation differed according to surgical technique. Associations of patient- and anatomy-related characteristics with intraoperative conditions and membrane perforation were also explored.
Statistical analyses included unadjusted between-group comparisons and multivariable analyses. The four co-primary outcomes were evaluated using separate multivariable linear regression models adjusted for age, RBH, sinus septa, smoking status, Schneiderian membrane thickness, and LWT, with heteroskedasticity-consistent HC3 standard errors. Membrane perforation was evaluated using multivariable binary logistic regression adjusted for the same patient- and anatomy-related covariates. Technique-dependent modification of the relationships between bleeding, visibility, procedural simplicity, and membrane perforation was assessed using separate multivariable logistic regression models containing surgical technique × intraoperative parameter interaction terms and adjusted for age, RBH, sinus septa, smoking status, Schneiderian membrane thickness, and LWT. Supportive exploratory analyses included correlation and non-parametric association analyses.
30 studies on the registry are indexed under Atrophic Maxilla; 11 are open to participants now.
This study's enrollment of 504 is above the median of 16 across 27 interventional studies indexed under Atrophic Maxilla.
Browse Atrophic Maxilla studies →Istanbul Aydın University is the lead sponsor of 70 studies on the registry; 18 are open to participants now.
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The criteria were revised on the registry on Sep 30, 2026. See what changed
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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 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.
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 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.
Time frame: 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.
Time frame: Immediately after completion of surgery
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.
Time frame: 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.
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
PDFs hosted by the registry, ClinicalTrials.gov.
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