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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

March 30, 2015
April 2, 2015
April 2, 2015
April 2015
December 2016   (Final data collection date for primary outcome measure)
  • vertical gain [ Time Frame: 9 months ]
    Measures will be taken from computerized tomography in axial sections
  • horizontal gain [ Time Frame: 9 months ]
    Measures will be taken from computerized tomography in transverse 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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Alveolar Bone Grafting
  • Bone Augmentation
  • 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
  • Experimental: Sausage graft
    Bone graft performed with a mixture of particulated autogenous and lyophilized bovine bone, stabilized with collagen membrane and pins.
    Interventions:
    • Procedure: Biopsy
    • Radiation: Computerized Tomography
    • Other: Standardized periapical radiographs
    • Other: Intraoral scanning
  • 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.
    Interventions:
    • Procedure: Biopsy
    • Radiation: Computerized Tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
24
Same as current
July 2017
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02406924
UniversidadeSP
No
Not Provided
Not Provided
Pedro Tortamano, University of Sao Paulo
Pedro Tortamano
Not Provided
Principal Investigator: Pedro Tortamano, PHD University of Sao Paulo
University of Sao Paulo
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP