Please click here if the newsletter does not display properly.

CleanImplant Newsletter 1 | 2022

EDITORIAL


Dear colleagues, friends and supporters.

For five years now, the independent CleanImplant Foundation has been evaluating the quality of dental implants worldwide and awarding its prestigious "Trusted Quality" award to implant types with particularly clean surfaces. The fact that these quality assessments, all of which are carried out in accredited testing laboratories, have not been received with enthusiasm by every manufacturer will come as no surprise to anyone.

However, when in extensive studies with various implants from more than 80 manufacturers, every third sterile delivered sample shows significant quantities of clinically relevant impurities on the surfaces, dentists and patients alike should become skeptical.

On the other hand, numerous manufacturers spare neither cost nor effort in quality management to deliver their medical devices as clean as technically possible. The stage belongs to them in the CleanImplant project, which is supported by countless colleagues and scientists worldwide. With more than 100,000 subscribers on Facebook alone, the CleanImplant Foundation's social media activities have gained a scale that none of the market-leading implant manufacturers would have thought possible.

These are all good reasons for us to take this opportunity to say a heartfelt thank you to all our supporters from practices, clinics, and universities around the world, the media, and last but not least, to implant manufacturers who care for their medical products in the best possible way.
Thanks for staying committed to CleanImplant in the coming year. We will not let up in our fight for a higher standard of implantology for us all.

Sincerely Yours,

Dirk U. Duddeck DDS.
On behalf of the CleanImplant Foundation


JOMI Publication: 
Comparative Study of Five Zirconia Implant Systems

Three ceramic implant systems revealed factory-related impurities. 

In October 2021, a scientific paper analyzing a total of 25 implant samples from five manufacturers was published in JOMI, the International Journal of Oral & Maxillofacial Implants. The study was initiated by Dirk U. Duddeck, CleanImplant's head of research and conducted with renowned scientists such as Tomas Albrektsson, Ann Wennerberg, Florian Beuer, and Jaafar Mouhyi.
 
The results of this study shows that it is possible to produce particle-free ceramic implant surfaces (according to the published CleanImplant's Guideline) which should, of course, be the aim for every implant material. The surfaces of the Champions (ZV3) implants and the Z-Systems implants were clean. In contrast, the other investigated surfaces of the vitaclinical, TAV Dental, and ZiBone implants revealed significant contamination on their surfaces.

Remarkable was the batch-spanning, packaging-related contamination of the first threads of all tested vitaclinical implants (see figure below). In a subsequent ToF-SIMS analysis, the vast quantities of particles could be identified as polyoxymethylene (polyacetal) .
This result has striking implications. On the one hand, it can be assumed that these significant amounts of plastic material were the initial cause of an uncontrolled foreign body reaction in the event of bone or implant loss. On the other hand, the medical device's packaging does not contain any warning notice for users or patients about the packaging residues of polyacetal.

A 12-page special print of this publication with impressive SEM images of all tested implants can be requested from the CleanImplant Foundation by sending an email to: JOMI-Study_2021@cleanimplant.com


Further Awards for Oral Implant Systems and a New Seal for Contract Manufacturers

Two implant systems have received the "CleanImplant Trusted Quality" award in the past year. With the titanium implant, Kontact S from the French manufacturer Biotech Dental and the ceramic system SDS 2.2 from the Swiss manufacturer Swiss Dental Solutions, 13 implant systems now meet the strict test criteria of our non-profit organization. More info about these implant types here on the CleanImplant website.

Fig.: The Biotech Dental Kontact S was awarded the Trusted Quality Seal in May 2021.
Find out more about this implant here.
Fig.: The SDS2.2 was awarded the Trusted Quality Seal in Ocotober 2021 at the first Joint Congress for Ceramic Implantology (JCCI).

More information about this zirconia implant system and the upcoming JCCI Congress in 2022 here.

In 2021 we have expanded our project with the "Certified Production Quality" award to welcome Contract Manufacturers of dental implants who agree to independent surveillance audits and the material testing of manufactured implants before they receive a label from the distributor and become a branded product.

CeramTec AG, market leader in medical ceramics, was the first contract manufacturer to receive this 
"Certified Production Quality" award for its zirconia implant production. The criteria for this award are essentially based on the existing CleanImplant quality guideline. Distributors with their own brand label can profit significantly from this Certified Production Quality award in the application process for the Trusted Quality Mark.



CleanImplant's YouTube Channel


If you would like to receive regular updates on videos, interviews, and short reports on quality assessment studies from the CleanImplant Foundation in the future,
you can sign up now for the CleanImplant Channel on YouTube. 




Follow this link to subscribe to the channel.

 
Ambassadors' Summit 2021 - Experts from 16 nations met at Lake Como 

In November 2021, members of the Scientific Advisory Board (Tomas Albrektsson, Michal Norton, Hugo de Bruyn, Jaafar Mouhyi, and Luigi Canullo) and CleanImplant Ambassadors - influential opinion leaders from 16 nations - accepted our invitation to the second Ambassadors' Summit in Villa Geno at Lake Como. Without the participation of media representatives or manufacturers, the framework for a confidential discussion of even difficult points was given.

Prof. Tomas Albrektsson of the Sahlgrenska Academy in Gothenburg emphasized in his presentation the need and requirement for implants to be sterile when they leave the factory and, of course, be free of foreign particles. Factory-related carbonaceous particles are suspected to be responsible for uncontrolled foreign body reactions. Residues of foreign metals also harbor the risk of undesirable corrosion.
Prof. Hugo de Bruyn, University of Nijmegen, presented preliminary results of a study analyzing the presence of metal particles in peri-implant sulcus fluid in correlation to the respective peri-implantitis status.
"How did dental implants become the most common medical device reported as failing to the FDA?" Data analyst and former FDA employee Madris Tomes reported live from Pennsylvania and helped interpret the skyrocketing FDA reports of oral implant losses. It appears that not only compromised patients or poorly trained dentists but also the high number of factory-contaminated dental implants are responsible for the rising number of reported implant losses.
Dr. Dirk U. Duddeck, head of research at the Foundation, summarized the results of a recent benchmark study on 100 implants in his presentation: "More than 30 percent of all previously sterile-packaged samples exposed significant factory-related contamination that could have been avoided with proper quality management." Dentists may unknowingly use these implants, putting not only patients' health at risk but also themselves, for there are also legal implications, including potential claims for damages.

The participants discussed strategies for supporting manufacturers who supply uncompromising medical devices and how the foundation can defend itself against increasing threats of legal action from manufacturers who offer implants of inferior quality. In the future, particular attention will be paid to those manufacturers who have failed to improve their quality management and implant production for years despite being informed of significant impurities on their implants. Instead, some have verbally attacked the scientists of the CleanImplant Foundation and even personally threatened them.

The short video linked gives an impression of this extraordinary expert meeting.


CleanImplant Certified Dentists 

You’re not yet a CleanImplant Certified Dentist? Then find the application form here: https://www.cleanimplant.com/dentists/index.php/ 
Certified Dentists receive personalized certificates, information about their implant system in use and marketing material to showcase their commitment to safer implantology and the CleanImplant Project. 
Patients can find CleanImplant Certified Dentists on the Internet worldwide. We provide information for patients, which not only draw attention to the problem of contaminated medical devices but also provide solutions and show the addresses of Certified Dentists: www.cleanimplants4u.com
(German version: www.saubere-implantate.de).



Upcoming Events - CleanImplant Experts on-site

If you would like to meet the people behind the CleanImplant project, get first-hand information about the current results of numerous implant tests, experience the scientific work and its conclusions, you will have several opportunities to do so until the Summer.


May 19-22, 2022



11TH IAOCI WORLD CONGRESS - CERAMIC IMPLANTOLOGY:
3 DAYS OF EXCEPTIONAL EDUCATION, HANDS-ON COURSES AND NETWORKING

Don't miss Washington in Spring. If you are already using zirconia implants or plan to give them a try, this is the place to be in 2021 to get a comprehensive overview.

With Sammy Noumbissi, the charismatic President of the International Academy of Ceramic Implantology, we can expect a great Congress with a fine line-up of speakers, such as Dr. Miguel Stanley, Dr. Saurabh Gupta, Dr. Diane Daubert, Dr. Joan Pi Anfruns, Dr. Marcus Seiler, Dr. Norbert Cionca, Dr. Andrea Borgonovo, Dr. Carlos Mourao, Dr. Georgios Kotsakis, and, of course, Dr. Sammy Noumbissi and Dr. Dirk Duddeck from the CleanImpalnt Foundation.
.

Topics are:
• New Generation of Zirconia Based Ceramic Materials
• The Corrosion Problem in Implant Dentistry
• Blood Concentrates for Optimal Bone Healing and Osseointegration
• Tissue & Cell Behaviour Towards Zirconia
• Comparison of Ceramic Implants under Quality Aspects
Get more information here.



May 27-29 May 2022

Venue: Seoul, South Korea
Detailed information about this Congress will be published shortly.

JUNE 9-11, 2022


Venue: Chia (Cagliari) – Sardegna, Italy
11th INTERNATIONAL AIO CONGRESS - ITALIAN DENTAL ASSOCIATION

FOCUS ON THE GENDER SHIFT IN DENTISTRY - A New Perspective or a Future Challenge?

Extraordinary Congress event in Sardegna with renowned speakers covering almost all aspects of dentistry, including the CleanImplant topic: Quality comparison of titanium and ceramic implants - Are factory-related contaminants an overlooked factor for peri-implantitis?
Dentistry has changed dramatically over the last decades. Aside from new technologies, procedures, and materials, one of the most important changes we have witnessed is in the gender shift in the profession, where the number of women practicing dentists is steadily increasing and where in many countries, women now make up from 50% to 70% of the total number of dental students. Dentistry is well on the way to becoming a female-dominated profession. The theme of the AIO International Congress, "Focus on the Gender Shift in Dentistry 2022: A New Perspective or a Future Challenge?" will explore this trend.

The stage will be set for these issues to be addressed in one of the most beautiful settings in the Mediterranean, on the enchanting island paradise of Sardegna, Italy, at the Chia Laguna Hotel and Resort, winner of the 2019 World Leading Beach Family Resort at the World Travel Awards.

Download all information about this Congress here.




Thank you for sharing this newsletter with colleagues and other stakeholders. :-)

Twitter Facebook Google Xing LinkedIn



We sent this email to unknown@noemail.com.
If you don't want to receive this Newsletter anymore,
click here to remove your Email address from our mailing list. 

 

CleanImplant Foundation CIF GmbH
Pariser Platz 4a
10117 Berlin
Germany


info@cleanimplant.org
www.cleanimplant.org
Managing Director: Dr. Dirk U. Duddeck
Registered / Handelsregister: HRB 179 652 B

The CleanImplant Foundation is a non-profit organization.