Intraoperative Outcomes, Postoperative Outcomes
Conditions
Brief summary
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.
Interventions
PROCEDURESinus floor elevation
DEVICESinus floor elevation using an ultrasonic device
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* edentulism in the posterior maxilla (unitary or plural) * need of a sinus floor augmentation procedure before implant placement
Exclusion criteria
* any uncontrolled systemic disease * ongoing chemo- or radiotherapy * history of maxillary sinus diseases or acute sinus-related issues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient related outcome measures (PROMs) | From right before the surgery up to 1 week postoperatively | 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. |
| Nasal discharge | From the end of surgery up to 1 week postoperatively | Presence/absence of nasal discharge postoperatively |
| NSAID consumption | From the end of surgery up to 1 week postoperatively | Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day) |
| Sinus membrane perforation | During the surgery (from beginning to end) | Presence/absence of sinus membrane perforation during the surgery |
| Surgical procedure duration | From beginning of surgery until the end of surgery | 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. |
| Edema | From the end of surgery up to 1 week postoperatively | Presence/absence of edema postoperatively |
| Hematoma | From the end of surgery up to 1 week postoperatively | Presence/absence of hematoma postoperatively |
| Postsurgical bleeding | From the end of surgery up to 1 week postoperatively | Presence/absence of bleeding postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival rates | From the baseline (surgery procedure) up to 1 year post-surgery | Implant survival rates assessment at 1 year postoperatively. |
| Radiographic outcomes | From the baseline (surgery procedure) up to 1 year post-surgery | Radiographic (CBCT) qualitative assessment of the gained volume (change in volume from baseline to 1 year postoperatively). |
Outcome results
None listed