Bone substitute biomaterials, such as xenografts (from other species) and allografts (from human donors), play an essential role in modern dentistry. These materials are widely used in bone regeneration, dental implantology, and oral surgery, providing a scaffold for new bone formation.
However, the quality and cleanliness of these biomaterials are crucial for patient safety and clinical success. With growing concerns about contaminants in dental implants, as highlighted by the CleanImplant Foundation, should we not also be examining the biomaterials that are placed inside human body?
This article explores:
– The history and evolution of bone substitute biomaterials,
– The science behind integration and why some materials fail,
– The current regulatory landscape and its gaps,
– The potential link between low-quality biomaterials and chronic illness,
– The importance of stringent manufacturing protocols,
– The role of patient health and surgical skill in success or failure, and
– A call to action for higher industry standards.
A Brief History of Bone Substitute Biomaterials
The concept of bone grafting has been around for centuries. The first known recorded use dates back to 1668, when Dutch surgeon Job van Meekeren successfully used a dog bone xenograft to repair a cranial defect in a soldier. However, due to religious beliefs at the time, the soldier refused to keep the “foreign” bone, and it had to be removed.
The Evolution of Bone Grafting in Dentistry
– Autografts (bone from the same patient) were long considered the gold standard but required additional surgery, increasing patient morbidity.
– Allografts (human donor bone) gained popularity in the 20th century with the rise of tissue banks, but concerns about immune response and disease transmission led to further innovation.
– Xenografts, especially bovine-derived bone, became a preferred option due to their availability and structural similarity to human bone.
Today, the most commonly used materials in regenerative dentistry are:
1. Bone substitutes (xenografts/allografts) – providing a scaffold for new bone growth.
2. Collagen membranes – protecting the graft, guiding tissue regeneration and giving certain stability to the site.
While these materials have revolutionized dentistry, their quality, cleanliness, and manufacturing processes are not always scrutinized at the level they should be.
Why Do Some Bone Grafts Fail? The Science Behind Biomaterial Integration
Not all biomaterials integrate successfully into the human body. While some biomaterials lead to osseointegration, others may resorb too quickly, cause inflammation, or fail to stimulate bone growth properly.
Key Factors Affecting Bone Graft Success
- Processing Techniques: Some companies use aggressive chemical processing or high-temperature treatments, which may damage the natural bone structure, making it less attractive to blood vessels and human cells.
Leading companies use a gentle and temperature-dependent treatment of the bone leaving the granules very similar to human bone. This is what we want, and not always the case.
4. Source of the Biomaterial: Some xenografts are derived from unregulated sources, leading to concerns about disease transmission and immune reactions.
However, failure is not always due to the material itself. Patient health, immune status, and surgical technique also play a critical role.
The Role of Patient Health & Surgical Skill
Much of the conversation around graft failure has focused on the patient’s systemic health and the surgeon’s technique—and rightly so. Common contributing factors include:
– Vitamin D deficiency – affecting bone metabolism and graft integration.
– Smoking – impairing healing and reducing blood flow to the surgical site.
– Thin biotypes – with less available soft tissue coverage, increasing exposure risk.
– Underlying immune conditions – impacting how well the body responds to the graft.
– Improper site preparation – failure to decontaminate the area properly before graft placement.
A well-trained surgeon understands that site preparation is key. Using lasers, ozone therapy, or ultrasonic debridement can optimize the receiving site by reducing bacterial contamination and enhancing biocompatibility.
That said, even when all of these factors are meticulously controlled—when the patient is healthy, the site is well-prepared, and the surgery is executed perfectly with tension-free closure—the quality of the bone graft can still determine success or failure.
This aspect is under-discussed in the field, as failures are often attributed solely to patient factors or surgical error. But shouldn’t the material itself be equally scrutinized?
Regulatory Standards: Are They Failing to Ensure Biomaterial Cleanliness?
Currently, FDA (U.S.) and CE (Europe) regulations primarily focus on sterility and biocompatibility rather than overall cleanliness[MP2].
– Sterility ensures the absence of bacteria, but it does not guarantee that the material is free of toxic contaminants or foreign particles.
– The CleanImplant Foundation has shown that many “sterile” dental implants contain organic and inorganic contaminants, which can lead to chronic health issues and systemic low grade inflammation.
Could the same be true for biomaterials like xenografts and allografts?
Investing in the Best Biomaterials
Companies that prioritize quality over speed and cost-cutting measures will naturally produce safer and more effective biomaterials.
One example is Swiss company Geistlich, specialized in regenerative biomaterials. Their products go through extensive processing and purification steps, ensuring:
– Outstanding osteo-conductive properties for optimal bone integration.
– No residual contaminants from processing.
– Proven long-term clinical success backed by scientific studies.
Arguably the Benchmark in biomaterials around the world.
If we are placing biomaterials inside human bone, shouldn’t we invest in the highest-quality options available?
Call to Action: What Needs to Change?
1. Stricter Regulatory Oversight
Regulatory agencies must go beyond sterility and examine biomaterials for:
– Chemical residues from processing
– Packaging contaminants
– Heavy metals or plastic particles
2. Greater Transparency from Manufacturers
Companies should be required to disclose full details on how their biomaterials are processed and tested for contaminants.
3. Clinicians Should Demand the Best for Their Patients
– Dentists and oral surgeons should question suppliers and only use biomaterials with proven biocompatibility and cleanliness.
– Patients should be educated on the potential risks of low-cost, unregulated bone grafts.
Conclusion: Prioritizing Safety and Quality in Dentistry
We must ensure that the materials we place in our patients’ bodies meet the highest safety standards. When patient health is optimized, surgical protocols are perfect, and the site is meticulously prepared, the biomaterial itself should not be the weakest link.
It’s time for stricter regulations, greater transparency, and a commitment to excellence in biomaterial science—because our patients deserve nothing less.
*Published in Miguel Stanley.
