Clinical Trial: Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase III, Randomized, Controlled Clinical Trial of Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

Brief Summary:

Since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed.

The aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects.

The investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.


Detailed Summary:
Sponsor: University of Zurich

Current Primary Outcome: Bone quality/quantity [ Time Frame: 4 month after augmentation surgery ]

Bone quantity at 4 months after augmentation surgery, measured manually by ridge measurements and volumetrically on the basis of optical impressions and radiological assessment (X-ray and cone beam CT). Bone quality at 4 months after augmentation surgery, measured by histological assessment (yields different proportion per patient).


Original Primary Outcome:

  • Bone quality/quantity [ Time Frame: 4 month after augmentation surgery ]
    Bone quantity at 4 months after augmentation surgery, measured manually by ridge measurements and volumetrically on the basis of optical impressions and radiological assessment (X-ray and cone beam CT). Bone quality at 4 months after augmentation surgery, measured by histological assessment (yields different proportion per patient).
  • Patient's perception/acceptance [ Time Frame: 8 days after augmentation surgery ]
    Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery)


Current Secondary Outcome:

  • Complications [ Time Frame: 8 days and 4 month after augmentation surgery ]
    Complications (soft tissue, sensitivity) measured at suture removal (8 days after augmentation surgery) and 4 months after augmentation surgery. Any adverse events will be recorded for the treatment period from visit 1 to 4.
  • Bone quantity [ Time Frame: at screening, augmentation surgery, suture removal, and during follow-up ]
    Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up
  • Patient's perception/acceptance [ Time Frame: 8 days after augmentation surgery ]
    Patient's perception/acceptance (visual analogue scale VAS) measured at suture removal (8 days after augmentation surgery)


Original Secondary Outcome:

  • Complications [ Time Frame: 8 days and 4 month after augmentation surgery ]
    Complications (soft tissue, sensitivity) measured at suture removal (8 days after augmentation surgery) and 4 months after augmentation surgery. Any adverse events will be recorded for the treatment period from visit 1 to 4.
  • Bone quantity [ Time Frame: at screening, augmentation surgery, suture removal, and during follow-up ]
    Bone quantity measured at screening, augmentation surgery, suture removal, and during follow-up


Information By: University of Zurich

Dates:
Date Received: February 23, 2012
Date Started: February 2011
Date Completion:
Last Updated: December 1, 2015
Last Verified: December 2015