Posterior Maxillary AtrophyNCT07794293
Comparison of Three Surgical Approaches for Lateral Sinus Floor Elevation
A study testing Conventional Rotary Lateral Sinus Floor Elevation, Epinephrine-Soaked Cotton Roll and Piezoelectric Sinus Lift in people with Posterior Maxillary Atrophy and Maxillary Sinus Augmentation, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Maxillary Atrophy, Maxillary Sinus Augmentation
- What is being tested?
- Conventional Rotary Lateral Sinus Floor Elevation, Epinephrine-Soaked Cotton Roll and Piezoelectric Sinus Lift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncontrolled systemic disease
- Known bleeding or coagulation disorders, including clinically relevant thrombocytopenia or platelet dysfunction
- Current use of anticoagulant or antiplatelet medications
- Pathological sinus mucosal thickening or other radiographic or clinical evidence of sinus disease
- Untreated periapical or periodontal infection adjacent to the maxillary sinus
- Antiresorptive therapy
Show all 10Show fewer
- 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
- Schneiderian membrane thickness >4 mm on preoperative CBCT in otherwise clinically and radiographically healthy sinuses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraoperative Conditions and Schneiderian Membrane Perforation Risk Among Three Surgical Approaches for Lateral Sinus Floor Elevation: A Prospective Comparative Study
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.
Read the detailed description
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.
- Being tested
- Conventional Rotary Lateral Sinus Floor Elevation, Epinephrine-Soaked Cotton Roll, Piezoelectric Sinus Lift
- Keywords
- Lateral Sinus Floor Elevation, Dental Implants, Schneiderian Membrane Perforation, Piezosurgery, Epinephrine-Soaked Cotton Roll, Surgical Simplicity, Surgical Visiblity, Operation Time, Residual Bone Height
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Rotary Lateral Sinus Floor ElevationProcedure or surgery
Also called Standard Procedure, SP
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.
Epinephrine-Soaked Cotton RollProcedure or surgery
Also called Epinephrine-Soaked Cottonoid-Assisted Lateral Sinus Floor Elevation, ESCR
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.
Piezoelectric Sinus LiftProcedure or surgery
Also called Piezoelectric Lateral Sinus Floor Elevation, PESL
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rotary Lateral Sinus Floor Elevation (SP) | Active comparator | 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. Receives: Procedure: Conventional Rotary Lateral Sinus Floor Elevation |
| Epinephrine-Soaked Cotton Roll (ESCR) | Experimental | 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. Receives: Procedure: Epinephrine-Soaked Cotton Roll |
| Piezoelectric Sinus Lift (PESL) | Experimental | 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. Receives: Procedure: Piezoelectric Sinus Lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the start to the completion of sinus membrane elevation
Secondary outcomes (1)
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.
Measured: During the surgical procedure, through completion of sinus membrane elevation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 May 2021
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Maxillary AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly allocated in a 1:1:1 ratio to one of three parallel intervention groups: standard procedure (SP), epinephrine-soaked cotton roll technique (ESCR), or piezoelectric sinus lift (PESL). A computer-generated randomization sequence with variable permuted blocks of 6, 9, and 12 was used. Allocation was concealed through a centralized electronic system and was released only after eligibility had been confirmed and written informed consent had been obtained. Each participant received only the allocated intervention, with no crossover between groups.
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kagan Degerliyurt, Istanbul Aydın University
- Investigators
- Mehmet Kagan Degerliyurt, DDS, PhD, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794293
- Sponsor's protocol ID
- IAU-DENT-OMFS-LSFE-2026-01
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative Conditions and Schneiderian Membrane Perforation Risk Among Three Surgical Approaches for Lateral Sinus Floor Elevation: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07794293
- Acronym / sponsor ID
- IAU-DENT-OMFS-LSFE-2026-01
- Keywords
- Lateral Sinus Floor Elevation, Dental Implants, Schneiderian Membrane Perforation, Piezosurgery, Epinephrine-Soaked Cotton Roll, Surgical Simplicity, Surgical Visiblity, Operation Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomly allocated in a 1:1:1 ratio to one of three parallel intervention groups: standard procedure (SP), epinephrine-soaked cotton roll technique (ESCR), or piezoelectric sinus lift (PESL). A computer-generated randomization sequence with variable permuted blocks of 6, 9, and 12 was used. Allocation was concealed through a centralized electronic system and was released only after eligibility had been confirmed and written informed consent had been obtained. Each participant received only the allocated intervention, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Conventional Rotary Lateral Sinus Floor Elevation (SP) | Active comparator | Procedure: Conventional Rotary Lateral Sinus Floor ElevationThe 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. |
| Epinephrine-Soaked Cotton Roll (ESCR) | Experimental | Procedure: Epinephrine-Soaked Cotton RollThe 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. |
| Piezoelectric Sinus Lift (PESL) | Experimental | Procedure: Piezoelectric Sinus LiftThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Uncontrolled systemic disease
- Known bleeding or coagulation disorders, including clinically relevant thrombocytopenia or platelet dysfunction
- Current use of anticoagulant or antiplatelet medications
- Pathological sinus mucosal thickening or other radiographic or clinical evidence of sinus disease
- Untreated periapical or periodontal infection adjacent to the maxillary sinus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Rotary Lateral Sinus Floor ElevationAlso: Standard Procedure, SPA 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. | Procedure or surgery | Conventional Rotary Lateral Sinus Floor Elevation (SP) |
| Epinephrine-Soaked Cotton RollAlso: Epinephrine-Soaked Cottonoid-Assisted Lateral Sinus Floor Elevation, ESCRA 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. | Procedure or surgery | Epinephrine-Soaked Cotton Roll (ESCR) |
| Piezoelectric Sinus LiftAlso: Piezoelectric Lateral Sinus Floor Elevation, PESLThe 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. | Procedure or surgery | Piezoelectric Sinus Lift (PESL) |
Primary outcome
Intraoperative bleeding score
Time frame: Immediately after completion of surgery
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.
Surgical Field Visibility Score
Time frame: Immediately after completion of surgery
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.
Procedural Simplicity Score
Time frame: Immediately after completion of surgery
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.
Operation time
Time frame: From the start to the completion of sinus membrane elevation
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.
1 secondary outcome
Intraoperative Schneiderian Membrane Perforation
Time frame: During the surgical procedure, through completion of sinus membrane elevation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet Kagan Degerliyurt, DDS, PhD principal investigator
Istanbul Aydın University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Rotary Lateral Sinus Floor Elevation, Epinephrine-Soaked Cotton Roll and Piezoelectric Sinus Lift in people with Posterior Maxillary Atrophy and Maxillary Sinus Augmentation, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative bleeding score (time frame: Immediately after completion of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.