Several approaches have been used in order to regenerate bone in the upper jaw in case of insufficient alveolar bone height for implant placement. However, new emerging techniques need to be assessed and compared to conventional methods in order to define their potential indications. The purpose of the present randomized controlled clinical trial was to compare the clinical outcomes of two sinus floor elevation techniques: conventional lateral window technique versus a novel transalveolar approach using hydrodynamic ultrasonic device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
Sinus membrane perforation
Presence/absence of sinus membrane perforation during the surgery
Time frame: During the surgery (from beginning to end)
Surgical procedure duration
The time measurement started from the administration of local anesthesia and ended when the placement of final suture was completed. The time was measured using a stopwatch.
Time frame: From beginning of surgery until the end of surgery
Edema
Presence/absence of edema postoperatively
Time frame: From the end of surgery up to 1 week postoperatively
Hematoma
Presence/absence of hematoma postoperatively
Time frame: From the end of surgery up to 1 week postoperatively
Postsurgical bleeding
Presence/absence of bleeding postoperatively
Time frame: From the end of surgery up to 1 week postoperatively
Nasal discharge
Presence/absence of nasal discharge postoperatively
Time frame: From the end of surgery up to 1 week postoperatively
NSAID consumption
Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)
Time frame: From the end of surgery up to 1 week postoperatively
Patient related outcome measures (PROMs)
PROMs were assessed with a questionnaire using a visual analogue scale (VAS), which was given to all participants in order to assess their perception before, during, and after the intervention. A graduated scale from 0 to 10 was used, with a lower score presenting a better outcome.
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Time frame: From right before the surgery up to 1 week postoperatively
Radiographic outcomes
Radiographic (CBCT) qualitative assessment of the gained volume (change in volume from baseline to 1 year postoperatively).
Time frame: From the baseline (surgery procedure) up to 1 year post-surgery
Implant survival rates
Implant survival rates assessment at 1 year postoperatively.
Time frame: From the baseline (surgery procedure) up to 1 year post-surgery