Publication: Bone Graft Breakdown Leads to Implant Loss

The following link takes you to a publication produced by Dr. Bach Le, an associate professor at the Herman Ostrow School of Dentistry at the University of Southern California. He documents bone graft failure and implant loss:

Bone graft breakdown has nothing to do with bacteria. It is simply a mechanical failure of the structure that supports the implant. It is an extension of the process that produces marginal bone loss. The following two studies confirm:

  • When implants are placed in cadaver bone grafts, marginal bone loss occurs
  • When implants are placed in normal bone, no marginal bone loss occurs
Relationship Between Osteoporosis and Marginal Bone Loss in Osseointegrated Implants: A 2-Year Retrospective Study.
J Periodontol. 2016 Jan;87(1):14-20. doi: 10.1902/jop.2015.150229. Epub 2015 Sep 3. Corcuera-Flores JR, Alonso-Domínguez AM, Serrera-Figallo MÁ, Torres-Lagares D, Castellanos-Cosano L, Machuca-Portillo G.
Crestal bone resorption in augmented bone using mineralized freeze-dried bone allograft or pristine bone during submerged implant healing: a prospective study in humans.
2016 Feb;27(2):e25-30. doi: 10.1111/clr.12512. Epub 2014 Nov 10. Huang HY, Ogata Y, Hanley J, Finkelman M, Hur Y

Marginal bone loss is produced by fracturing of the bone at the crest. Normal bone is flexible and adapts to the stress of implant placement and that is why normal bone does not produce marginal bone loss. Allografts, xenografts, and non-resorbable synthetics build up fractures in the graft site over time until the bone that supports the implant collapses. What the dental profession does not know is that this is nothing new to the FDA.

The FDA does not allow implants to be placed in any bone graft material that does not produce normal bone. The FDA will not allow these products to be marketed for supporting dental implants. Therefore, when you shop online for bone grafts, you will not see implants placed in bone grafts on a company’s promotional materials. These companies hire clinicians to show you how to place implants in their bone grafts without telling you that the FDA prohibits that use of their products. The following is what these materials are approved for by the FDA and you will never see that you can place implants into sites grafted with the material.

This is the intended use of a common mineralized allograft:

  • A bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: Iocalized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection apicoectomy, and periodontal defects.

 

This is the intended use of a common xenograft:

  • Augmentation or reconstructive treatment of the alveolar ridge;
  • Filling of infrabony periodontal defects;
  • Filling of defects after root resection, apicoectomy, and cystectomy;
  • Filling of extraction sockets to enhance preservation of the alveolar ridge;
  • Elevation of the maxillary sinus floor;
  • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
  • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

 

The intended use of a common non-resorbable synthetic:

  • Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
Whenever dentists use these materials to support dental implants, they are using the material off label and the dentist is liable for the failure, not the manufacturer.

SteinerBio has been studying implant failure for many years. Implant success is at the heart of what we do and it is critical that we understand the circumstances that result in implant failure. For 10 years we have been warning the profession that the increase in implant failures is a result of placing implants in bone that is not normal and as many of you know, we have been condemned for pointing out the obvious.

Dr. Le’s contribution cannot be overstated and it cannot be ignored. When dentists begin to put bone graft failure into their differential diagnosis, they will quickly see the types of bone grafts that result in implant loss. When these materials are avoided, we will all be seeing a 99% success rate over time. For more information on how various bone grafts fail please read the following:
How Cadaver Bone Transplants Mineralize and Sclerotic Bone Fails.
Steiner, G. How Cadaver Bone Transplants Mineralize and Sclerotic Bone Fails. Preprints 2018, 2018100300 (doi: 10.20944/preprints201810.0300.v1).

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