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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

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE April 2, 2015
Last Update Posted Date April 2, 2015
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bone Augmentation Using Particulated Biomaterial and Autogenous Bone, Stabilized by Collagen Membrane and Pins (PaMP)
Official Title  ICMJE Maxillary Horizontal and Vertical Bone Augmentation Using Particulated Biomaterial Associated With Autogenous Bone, Covered and Stabilized by a Collagen Membrane and Pins
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alveolar Bone Grafting
  • Bone Augmentation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 1, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2017
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02406924
Other Study ID Numbers  ICMJE UniversidadeSP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pedro Tortamano, University of Sao Paulo
Study Sponsor  ICMJE Pedro Tortamano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pedro Tortamano, PHD University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date April 2015

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