NCT06055127

Osseodensifiction Versus Piezoelectric Internal Sinus Elevation Technique in Delayed Implant Placement

Osseodensifiction Versus Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement (A Randomized Controlled Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The present study is a parallel single-blinded randomized controlled clinical trial. The study will be conducted after being reviewed and approved by the Faculty of Dentistry, AinShams University Research Ethics Committee (FDASU-REC). The study population will be randomly allocated into two groups of the same size: Group 1: Osseodensifiction sinus lift will be performed using sticky bone as a graft material. Group 2: Piezoelectric Internal Sinus Elevation (PISE) will be performed using sticky bone as a graft material. The aim of the present study is to evaluate the effectiveness and clinical results of osseodensification in comparison to Piezoelectric Internal Sinus Elevation (PISE) Technique in Delayed Implant Placement.

Conditions

• Maxillary Sinus Floor Augmentation

Interventions

Type	Name	Description
PROCEDURE	osseodensifiction internal sinus lift / sticky bone graft material	The osteotomy for the osseodensification internal sinus lift begins with a twist drill advanced at 800 rpm with saline irrigation to within 1-2 mm from the sinus floor. Next, a series of osteotomy drills are used in the same fashion at 800 rpm to widen the osteotomy. The final osteotomy drill is advanced with gentle pressure at 100 rpm counterclockwise without irrigation until a bouncing sensation occurs "haptic feedback" at this point infracture of the sinus has taken place. After infracture, injection of the graft material into the osteotomy site will occur. The final osteotomy drill is used to guide the graft apically. This process is repeated in an incremental fashion to lift the membrane. Once enough space has been created below the antral membrane, implant insertion will occur then suturing.
PROCEDURE	piezoelectric internal sinus lift / sticky bone graft material	In the PISE technique, an ultrasonic piezoelectric device (acteon), to which a specialized tip is attached, is used to break the sinus floor. Developed for sinus lift by the crestal approach, the Intralift™ Kit makes it possible to undertake dental non invasive surgery in full safety. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and gradually widen the access canal to the sinus membrane. The sterile spray cools the tips down to avoid any rise in temperature, which could lead to oral tissue damage.The membrane elevation is achieved using the TKW5 by means of microcavitation. Thanks to the ultrasonic frequency modulation, the risk of membrane damage is limited. Moreover, the cavitation effect enables excellent visibility of the operating field.

Timeline

• Start date: 2023-09-08
• Primary completion: 2024-01-30
• Completion: 2024-05-31
• First posted: 2023-09-26
• Last updated: 2024-07-31

Locations

1 site across 1 country: Egypt