Evaluation of a Lateral Window Technique Augmentation for Maxillary Sinus Using Ultrasound Activated Pins

Summary

Ultrasound activated pins have been used for the promotion of bone healing in combination with biodegradable membranes during bone grafting procedures. In the jaws, these pins have been successfully tested for both maxillary and mandibular ridge augmentaton. However, the usefulness of these pins in maxillary sinus lift procedures has not been tested. This study aims to use a bilateral split mouth design to compare the bone formation, healing and post-operative complications after the use of ultrasonic guided pins in a lateral window maxillary sinus augmentation procedure in comparison to lateral window maxillary sinus augmentation procedure procedure performed without the use of these pins.

Conditions

• Tooth Loss

Interventions

PROCEDURE

Lateral Window Technique Augmentation for Maxillary Sinus

Maxillary sinus augmentation will be performed using the lateral window technique

DEVICE

Ultrasound activated resorbable poly-D-L-lactide pins

The titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins

DEVICE

Purus® Cancellous Allograft

Allograft material placed in the sinus to acheive sinus augmentation

DEVICE

Resorb X Membrane

The membrane placed over the graft material before placement of the ultrasound activated pins

DEVICE

Biomend

Collagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used

PROCEDURE

Cone Beam CT image of the Sinus

Cone beam CT will used to assess the thickness of bone formation after the placement of the graft

PROCEDURE

Trephine Biopsy

Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed

Sponsors & Collaborators

• King Saud Medical City

  collaborator OTHER_GOV

• Riyadh Colleges of Dentistry and Pharmacy

  lead OTHER

Principal Investigators

• Bishi AlGarni, MSc · Riyadh Colleges of Dentistry and Pharmacy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

45 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2016-05-31

Completion

2016-08-31

Countries

• Saudi Arabia

Study Locations