When choosing an implant, most patients look at the brand, price and country of origin. In recent years a less-discussed quality indicator has come to the fore: is the implant surface really clean the moment it leaves the packaging? In this article we explain why implant surface cleanliness matters, how the SEM/EDS test is performed and how a test report should be read. As an example we use the preliminary report published by the CleanImplant Foundation for the BEGO Semados TiPure+ implant.
What does contamination on an implant surface mean?
Dental implants are packed sterile, meaning the aim is that no living microorganisms are present on them. However, being “sterile” and having a “completely clean surface” are not the same thing. Sterilisation destroys microbes but does not remove non-living particles that stuck to the surface during production. These particles may be:
- Organic residues: Carbon-based particles that may come from plastic packaging, gloves or processing fluids
- Metallic particles: Stainless steel (iron, chromium, nickel) from manufacturing tools, or elements such as copper and tin
- Blasting residues: Particles such as aluminium oxide used to roughen the surface
The CleanImplant Foundation states that such residues are suspected of being linked in some cases to incomplete fusion of the implant with the bone or to early bone loss. The word “suspected” is important here: the relationship between residues and clinical outcomes is still being researched and should not be presented as a proven cause-and-effect link.
Does CE or FDA approval indicate surface cleanliness?
One notable finding in the foundation’s report is that the CE mark or US FDA clearance is not a reliable indicator of the purity of an implant surface. These approvals show the legal processes required for a product to go on the market; they do not mean that the surface of every production batch has been examined for particles under a microscope. For this reason, some manufacturers and clinics use additional surface analyses carried out in independent laboratories as a quality indicator.
How is the SEM/EDS test performed?
The CleanImplant Foundation’s 2017–2019 study protocol includes several precautions to ensure reliable results:
- Clean-room conditions: Implants are removed from their packaging in an ISO class 5 (DIN EN ISO 14644-1) clean room. This prevents contamination from the air or hands reaching the surface being examined.
- Contact-free mounting: The implant is held with sterile tweezers and fixed to the sample holder without the surface to be analysed touching anything.
- Accredited laboratory: Analyses are performed in an independent test laboratory accredited to DIN EN ISO/IEC 17025.
- Full surface map: The implant is scanned at about 500× magnification; more than 360 images are stitched together into a single high-resolution image (FSHR) showing most of the surface. Particles are counted on this image and suspicious areas marked.
- Close inspection and elemental analysis: The marked spots are examined at up to 10,000× magnification, and EDS is used to identify the elements at these spots.
What is the difference between SEM and EDS?
| SEM (scanning electron microscope) | EDS (energy-dispersive X-ray spectroscopy) | |
|---|---|---|
| What does it do? | Creates an image of the surface at very high magnification | Identifies the chemical elements in the imaged area |
| Which question does it answer? | “Are there particles on the surface, where and how large?” | “What is this particle made of?” |
| What does it look like? | Black-and-white images showing material contrast; organic residues usually appear dark, heavy metals light | A spectrum graph with a characteristic peak for each element |
| Limitation | Does not reveal chemical composition on its own | Spot- or area-based; does not analyse the whole implant at once |
Reports often include an “area analysis” and one or more “spot analyses”. The area analysis gives the overall composition of the region in the microscope’s focus. The spot analysis focuses on a single particle. In some reports the difference between the two measurements is taken (differential spectrum) to remove the signal from the implant’s own titanium so that the signal from the foreign material on the surface can be seen more clearly.
Example report: what does the BEGO Semados TiPure+ result show?
In the CleanImplant Foundation’s preliminary report dated 10 December 2019, a single BEGO Semados implant with a TiPure+ surface, 4.5 mm in diameter and 11.5 mm long (from a specific production batch), was examined. The analyses were performed in March 2019 at an independent materials research laboratory in Berlin.
According to the report’s summary, a single carbon-based particle about 10–20 micrometres in diameter was detected on the sample examined. In other words, the report indicates that the surface was largely free of particles, but that a small residue thought to be of organic origin was detected.
To interpret this result correctly, keep the following in mind:
- The report is a preliminary report and relates to a single sample; it should not be assumed to represent all production batches or the entire product family.
- The report shows the surface condition at that moment; it gives no direct information about the implant’s clinical success rate.
- This preliminary report does not in itself amount to a certificate or award. The foundation has a separate certification process, which involves examining several samples.
Is surface cleanliness the only factor in implant success?
No. Surface quality is an important part, but the long-term outcome of implant treatment depends on many factors:
- Bone quantity and quality, proper planning and surgical technique
- Gum health; regular periodontal follow-up, especially for patients with a history of periodontitis
- Systemic factors such as smoking and diabetes
- Correct prosthesis design that can be cleaned
- The patient’s home oral care and regular attendance at check-ups
From a periodontology point of view, one of the most important causes of inflammation around implants (peri-implantitis) is bacterial plaque. Therefore, even an implant with the cleanest surface may not stay healthy for long without good oral hygiene and professional maintenance.
How do we approach this at our clinic?
At Yayla Dental Akademi in Istanbul we use IZEN Zenex implants certified by the CleanImplant Foundation. We explain what the certificate means and the features of these implants in detail on our Clean Implant and IZEN Zenex page. Which implant is right for you is determined after examination, CBCT imaging and a periodontal assessment.
Frequently asked questions
Can a sterile implant have residues on its surface?
Yes, it can. Sterilisation kills living microorganisms, but it does not remove non-living particles that stuck to the surface during manufacturing or packaging. These particles can be detected with SEM/EDS analysis.
Is the SEM/EDS test performed on the patient?
No. The test is done in a laboratory on an implant removed from its packaging under clean-room conditions. No procedure is performed on the patient; the test is for quality assessment by the manufacturer or independent organisations.
What was found in the BEGO Semados implant report?
The CleanImplant Foundation’s 2019 preliminary report stated that a single carbon-based particle about 10–20 micrometres in diameter was found on the one BEGO Semados TiPure+ implant examined. The report relates to a single sample.
Does an implant with a clean surface eliminate the risk of peri-implantitis?
No. The main cause of peri-implantitis is bacterial plaque. Although surface quality is an important factor, oral hygiene, gum health, smoking and regular check-ups are the key factors determining the long-term result.
Is the Clean Implant certificate the same as a single test report?
No. A single preliminary report shows the surface condition of a particular sample at that moment. The CleanImplant Foundation’s certification process involves examining several samples against defined criteria.
Related pages
Appointments and information: For questions you can message us on WhatsApp or call Yayla Dental Akademi in Istanbul on +90 544 289 66 33.
Sources: Duddeck DU (CleanImplant Foundation), Implant Study 2017–2019: On Cleanliness of Sterile Dental Implants – A Global Quality Assessment of Implant Surfaces by SEM/EDS Analysis, Preliminary study report (Bego Implant Systems, Semados TiPure+), 2019; BEGO Implant Systems, Partners in Progress – Product catalogue, 07/2021; Berglundh T, Armitage G et al., Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop, Journal of Periodontology, 2018.
This article is for information only; diagnosis and treatment planning can only be determined by a dentist after an examination.
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\"Dr. Dt. Mehmet Fuat Bozaba, İstanbul Medipol Üniversitesi Periodontoloji Anabilim Dalı\'nda doktorasını tamamlamış uzman diş hekimidir. Bahçelievler\'de Yayla Dental Akademi bünyesinde ileri klinik uygulamalarla hizmet vermektedir. Temel uzmanlık alanları arasında dental implantlar, Khoury ve Urban teknikleriyle ileri kemik rejenerasyonu ve diş eti çekilmelerinin tedavisi (pembe estetik) yer almaktadır. Bugüne kadar 1000\'den fazla implant ve gömülü yirmilik yaş diş cerrahisi ile 700\'ü aşkın diş eti grefti operasyonunu başarıyla gerçekleştirmiştir. Sağlık turizmi kapsamında yurt dışından gelen hastalar için ileri düzeyde İngilizce dilinde tedavi imkanı sunmaktadır.\"
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