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Clinical Trials/NCT02406924
NCT02406924
Unknown
Not Applicable

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

Pedro Tortamano0 sites24 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alveolar Bone Grafting
Sponsor
Pedro Tortamano
Enrollment
24
Primary Endpoint
vertical gain
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
July 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pedro Tortamano
Responsible Party
Sponsor Investigator
Principal Investigator

Pedro Tortamano

PHD

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • absence of teeth at anterior maxilla
  • need of vertical or horizontal bone reconstruction at anterior maxilla

Exclusion Criteria

  • smoking habits
  • systemic diseases which interfere with osseous metabolism
  • active periodontal disease

Outcomes

Primary Outcomes

vertical gain

Time Frame: 9 months

Measures will be taken from computerized tomography in axial sections

implants survival

Time Frame: 24 months

Clinical examination and standardized radiographs will be taken periodically

soft tissue volume

Time Frame: 24 months

Measures will be taken from images generated by intraoral scanning in an occlusal view

horizontal gain

Time Frame: 9 months

Measures will be taken from computerized tomography in transverse sections

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