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

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ClinicalTrials.gov Identifier: NCT02406924
Recruitment Status : Unknown
Verified April 2015 by Pedro Tortamano, University of Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : April 2, 2015
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
Pedro Tortamano, University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alveolar Bone Grafting Bone Augmentation Procedure: Biopsy Radiation: Computerized Tomography Other: Standardized periapical radiographs Other: Intraoral scanning Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
Study Start Date : April 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sausage graft
Bone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins.
 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
Active Comparator: Bone block graft
Bone graft performed with a block of autogenous bone stabilized by a screw associated with lyophilized bovine bone and collagen membrane.
 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


Outcome Measures
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Primary Outcome Measures :
  1. vertical gain [ Time Frame: 9 months ]
    Measures will be taken from computerized tomography in axial sections

  2. horizontal gain [ Time Frame: 9 months ]
    Measures will be taken from computerized tomography in transverse sections

  3. implants survival [ Time Frame: 24 months ]
    Clinical examination and standardized radiographs will be taken periodically

  4. soft tissue volume [ Time Frame: 24 months ]
    Measures will be taken from images generated by intraoral scanning in an occlusal view


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • smoking habits
  • diabetes
  • systemic diseases which interfere with osseous metabolism
  • active periodontal disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406924


Contacts
Contact: Caroline B Keedi, MSD 55 11 997981436 carolbkeedi@gmail.com
Contact: Patricia S Gimenez, MSD 55 11 983832404 patsgimenez@gmail.com

Sponsors and Collaborators
Pedro Tortamano
Investigators
Principal Investigator: Pedro Tortamano, PHD University of Sao Paulo
More Information
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Responsible Party: Pedro Tortamano, PHD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02406924     History of Changes
Other Study ID Numbers: UniversidadeSP
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: April 2015

Keywords provided by Pedro Tortamano, University of Sao Paulo:
pin
particulated graft
bone augmentation
vertical augmentation
horizontal augmentation