Are your dental implants actually clean as promised?

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Posted by: Dental Design 24th November 2022

Complications which occur after dental implant placement are often attributed to the patient’s oral hygiene, or the dentist’s lack of education and/or experience. However, the professors and practitioners at the CleanImplant Foundation believe that contaminated dental implants could be the cause of peri-implantitis in more cases than many would expect.

The CleanImplant Foundation was established in Germany by Dr Dirk Duddeck, dentist and biologist, who explains more about the organisation, its aims and the importance of truly clean dental implants:

“At the CleanImplant Foundation we conduct a quality assessment of approx. 100 sterile-packaged dental implants from different brands every 2 to 3 years. Over the years we have analysed a total of more than 300 different dental implant types from 200 companies using the Scanning Electron Microscope. The astounding result: approximately one-third of all tested implant samples are contaminated with significant residue from the manufacturing process or contaminants attributable to the packaging process. The dental implant surface debris most frequently evidenced were different carbonaceous compounds identified, e.g. synthetic polymers, thermoplastic materials, Perfluoropolyether (PFPE) – all of them are known to exhibit toxic effects. Significant residues of Dodecylbenzene-sulfonic acid (DBSA) were also found on surfaces of sterile-packaged dental implants. Remnants of this aggressive and surface-active cleaning chemical are cell-toxic and classified as ‘hazardous’ according to the US Environmental Protection Agency (EPA).

“The clinical relevance of dental implant surface contaminants is no longer in dispute. Many peer-reviewed studies conclude that residue on the surface presents a significant concern for treatment success. Organic carbonaceous pollutants are shown to be associated with initial bone loss or peri-implantitis. Foreign particles of 0.2 to 7.2 µm are acknowledged to be highly pro-inflammatory. Should these particles detach from the surface during dental implant insertion, they can create an expanding zone of soft tissue degradation. The secretion of TNF-α, IL-1b, IL-6, and PGE2 from the inflammation zone can stimulate the differentiation of osteoclast precursors into mature osteoclasts. All contaminants mentioned above have been shown to disturb the patient-specific foreign body equilibrium, a major cause of peri-implant bone loss, as stated by Tomas Albrektsson.

“There are numerous dental implant brands available today and they all advertise their products to be clean, however, the data we have collected shows this is not always the case. In fact, there are many dental implants on the market of inferior quality.

“When we are faced with patients complaining about their care and losing trust in our treatment abilities, we must consider the causes very carefully – and it is not always the dentist’s skill, or the technique used. Colleagues should demand flawless quality when it comes to the surface cleanliness of a dental implant to prevent the product from being the problem.

“Unfortunately, it can be very difficult for dentists to know which products are clean. Even brand reputation, size and origin, CE labels or FDA clearance do not prove that products are clean. As a matter of fact, even some of the biggest companies don’t have full control over their production processes.”

The CleanImplant Foundation aims to help clinicians choose only truly clean implants to promote patient safety and improved treatment outcomes. Though not always a comfortable topic for some manufacturers, the CleanImplant Foundation strives to be completely transparent in everything that they do and find. Dr Duddeck continues:

“The CleanImplant Foundation is a non-profit organisation who guarantee total transparency and 100% unbiased analyses. Results are peer-reviewed by some of the most renowned scientists, including Professor Dr Tomas Albrektsson and Dr Michael R. Norton (Past President of the Academy of Osseointegration). In 2017, we developed the first consensus paper to establish a threshold of acceptable contamination, defining what makes a dental implant ‘clean’. The companies whose products meet our requirements understand the problem. They have invested money, time, effort and extensive human resources on improving their production processes and corresponding quality management as a result. The CleanImplant Trusted Quality Seal gives dentists the information and confidence they need to make informed decisions about the dental implants they use. Our objective is not to blame companies, but to raise awareness and enhance standards across the profession for the benefit of our patients.”

When asked about the impact of this non-profit initiative on the dental market, Dr Duddeck summarised:

“We now have more than 120k followers on social media, which we have accumulated in only 3 years. Respect is earned but we have made a very strong start, and I’m confident that we’re on the right track. To date more than 40 key opinion leaders share our passion and believe in what we’re trying to achieve. We offer a fantastic opportunity for dental implant suppliers and industry partners to apply for a Trusted Quality Seal to demonstrate their commitment to quality as well.

To cite Tomas Albrektsson, ‘We have to know, not believe, that a specific implant is without harm to our patients’.[i] This is our mantra. We are providing dental professionals with this knowledge.”

Dr Duddeck will be among the many highly esteemed speakers at the ADI Team Congress 2023. He tells us what he hopes colleagues will gain from his session:

“I hope delegates will ask their sales representatives if they have unbiased proof that their dental implant is as clean as they say. I will encourage colleagues to question the promised quality of the dental implants they purchase. If they are unknowingly using a product that is not as clean as they think, they could be looking in the wrong areas to determine why their patients experience peri-implantitis.

“I am very excited to speak for the ADI for the first time and look forward to sharing more of our findings with peers in the UK.”

The ADI Team Congress 2023 will be held on 4-6 May at the Birmingham ICC. Visit the website for details in due course. ADI members get significantly discounted rates for all ADI events.

www.adi.org.uk

[i] Albrektsson, Tomas, et al. “Survival of NobelDirect implants: an analysis of 550 consecutively placed implants at 18 different clinical centers.” Clinical implant dentistry and related research 9.2 (2007): 65-70.

Fig.1: Sterile does not necessarily means the same as clean. Avoidable organic, carbon-containing contaminants (sample above) are clinically relevant as they are linked to bone loss and/or peri-implantitis. (SEM Mapping image in BSE mode shows two different new dental implants in comparison)