Maxillary Sinus Augmentation, Posterior Maxillary Atrophy
Conditions
Keywords
Lateral Sinus Floor Elevation, Dental Implants, Schneiderian Membrane Perforation, Piezosurgery, Epinephrine-Soaked Cotton Roll, Surgical Simplicity, Surgical Visiblity, Operation Time, Residual Bone Height
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREConventional Rotary Lateral Sinus Floor Elevation
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.
PROCEDUREEpinephrine-Soaked Cotton Roll
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.
PROCEDUREPiezoelectric Sinus Lift
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.
Sponsors
Istanbul Aydın University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Participants were randomly assigned in a 1:1:1 ratio to one of three parallel intervention groups: standard procedure (SP), epinephrine-soaked cotton roll (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 until eligibility was confirmed and written informed consent was obtained. Each participant received only the assigned intervention, with no crossover between groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative bleeding score | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Schneiderian Membrane Perforation | During the surgical procedure, through completion of sinus membrane elevation | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMehmet Kagan Degerliyurt, DDS, PhD
Istanbul Aydın University
Outcome results
None listed