Lateral Window Versus Intralift™ Sinus Floor Elevation

NCT04499625 | Completed

• 1 other identifier: B707201316423
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intraoperative Outcomes; Postoperative Outcomes

Outcome Measures

Primary Outcomes (8)

• Sinus membrane perforation

  Presence/absence of sinus membrane perforation during the surgery

  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.

  From beginning of surgery until the end of surgery

• Edema

  Presence/absence of edema postoperatively

  From the end of surgery up to 1 week postoperatively

• Hematoma

  Presence/absence of hematoma postoperatively

  From the end of surgery up to 1 week postoperatively

• Postsurgical bleeding

  Presence/absence of bleeding postoperatively

  From the end of surgery up to 1 week postoperatively

• Nasal discharge

  Presence/absence of nasal discharge postoperatively

  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)

  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.

  From right before the surgery up to 1 week postoperatively

Secondary Outcomes (2)

• Radiographic outcomes

  From the baseline (surgery procedure) up to 1 year post-surgery

• Implant survival rates

  From the baseline (surgery procedure) up to 1 year post-surgery

Study Arms (2)

Control - Lateral window

OTHER

Standard surgical technique to access maxillary sinus for sinus floor augmentation procedure.

Procedure: Sinus floor elevation

Test - Hydrodynamic transalveolar approach

EXPERIMENTAL

Novel transalveolar approach (using an ultrasonic device) to access maxillary sinus for sinus floor augmentation procedure.

Device: Sinus floor elevation using an ultrasonic device

Interventions

Sinus floor elevation PROCEDURE

Control - Lateral window

Sinus floor elevation using an ultrasonic device DEVICE

Test - Hydrodynamic transalveolar approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• edentulism in the posterior maxilla (unitary or plural)
• need of a sinus floor augmentation procedure before implant placement

You may not qualify if:

• any uncontrolled systemic disease
• ongoing chemo- or radiotherapy
• history of maxillary sinus diseases or acute sinus-related issues

Sponsors & Collaborators

• University of Liege: lead

Related Publications (1)

• Bacevic M, Compeyron Y, Lecloux G, Rompen E, Lambert F. Intraoperative and postoperative outcomes of sinus floor elevation using the lateral window technique versus the hydrodynamic transalveolar approach: a preliminary randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5391-5401. doi: 10.1007/s00784-021-03847-2. Epub 2021 Mar 10.

  PMID: 33694027 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: August 5, 2020
• Study Start: May 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: August 5, 2020

Record last verified: 2020-07