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OpenTrials
Completed

NCT Number: NCT04499625

Lateral Window Versus Intralift™ Sinus Floor Elevation

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.

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Key information

Conditions

Intraoperative Outcomes Postoperative Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sinus floor elevation

Procedure

Sinus floor elevation using an ultrasonic device

Device

Primary outcomes

  1. Sinus membrane perforation

    Time frame: During the surgery (from beginning to end)

    Presence/absence of sinus membrane perforation during the surgery

  2. Surgical procedure duration

    Time frame: 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.

  3. Edema

    Time frame: From the end of surgery up to 1 week postoperatively

    Presence/absence of edema postoperatively

  4. Hematoma

    Time frame: From the end of surgery up to 1 week postoperatively

    Presence/absence of hematoma postoperatively

  5. Postsurgical bleeding

    Time frame: From the end of surgery up to 1 week postoperatively

    Presence/absence of bleeding postoperatively

  6. Nasal discharge

    Time frame: From the end of surgery up to 1 week postoperatively

    Presence/absence of nasal discharge postoperatively

  7. NSAID consumption

    Time frame: From the end of surgery up to 1 week postoperatively

    Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)

  8. Patient related outcome measures (PROMs)

    Time frame: 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.

Secondary outcomes

  1. Radiographic outcomes

    Time frame: 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).

  2. Implant survival rates

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

    Implant survival rates assessment at 1 year postoperatively.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 5, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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