NCT02406924

Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP)

Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Pedro Tortamano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Twenty four patients with bone resorption on the anterior maxilla will be divided into two groups with different kinds of grafting: bone block associated with particulated biomaterial and particulated mixture of autogenous bone and biomaterial stabilized by collagen membrane and pins. The techniques will be compared according to volume gain, quality of graft osseointegration, implant survival and maintenance of the level of soft tissues.

Detailed description

Twenty four patients will be selected analysing the resorption on the front maxilla and will be divided into two groups. Experimental group will receive a particulated mixture of autogenous and lyophilized bovine bone, stabilized with a collagen membrane and pins over the vertical and/or horizontal defect, while Control group will receive a bone block graft, stabilized with fixation screws , covered with lyophilized bone and a collagen membrane. After a period of nine months, the volume increase will be measured trough the difference found between the initial computerized tomography and the final computerized tomography. Dental implants will be placed according to the prosthetic need and bone cylinders will be removed from the respective location. The cylinders will be histologically analysed in order to verify the quality of the graft osteointegration. After the prosthesis installation, the implant survival and the soft and hard tissues will be followed up for a minimum period of 24 months.

Conditions

• Alveolar Bone Grafting
• Bone Augmentation

Interventions

Type	Name	Description
PROCEDURE	Biopsy	A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine
RADIATION	Computerized Tomography	An initial computerized tomography will be made before the first surgery, and a final computerized tomography will be made after 9 months, previously to the second surgery
OTHER	Standardized periapical radiographs	A device will be adopted for the standardization, and radiographs will be taken at day 0, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
OTHER	Intraoral scanning	Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-12-01
• Completion: 2017-07-01
• First posted: 2015-04-02
• Last updated: 2015-04-02