Lateral Window Versus Intralift™ Sinus Floor Elevation

Postoperative Outcomes Clinical Trial

Official title:

Intraoperative and Postoperative Outcomes of Sinus Floor Elevation Using Lateral Window Technique Versus Hydrodynamic Transalveolar Approach: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499625
• Other study ID #: B707201316423
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: May 2018

Study information

• Verified date: July 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intraoperative Outcomes
• Postoperative Outcomes

Intervention

Procedure:
• Sinus floor elevation

Device:
• Sinus floor elevation using an ultrasonic device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sinus membrane perforation	Presence/absence of sinus membrane perforation during the surgery	During the surgery (from beginning to end)
Primary	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.	From beginning of surgery until the end of surgery
Primary	Edema	Presence/absence of edema postoperatively	From the end of surgery up to 1 week postoperatively
Primary	Hematoma	Presence/absence of hematoma postoperatively	From the end of surgery up to 1 week postoperatively
Primary	Postsurgical bleeding	Presence/absence of bleeding postoperatively	From the end of surgery up to 1 week postoperatively
Primary	Nasal discharge	Presence/absence of nasal discharge postoperatively	From the end of surgery up to 1 week postoperatively
Primary	NSAID consumption	Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)	From the end of surgery up to 1 week postoperatively
Primary	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.	From right before the surgery up to 1 week postoperatively
Secondary	Radiographic outcomes	Radiographic (CBCT) qualitative assessment of the gained volume (change in volume from baseline to 1 year postoperatively).	From the baseline (surgery procedure) up to 1 year post-surgery
Secondary	Implant survival rates	Implant survival rates assessment at 1 year postoperatively.	From the baseline (surgery procedure) up to 1 year post-surgery