*2.2. Clinical Documentation of OsseoSpeed, SLA, and TiUnite Implant Systems*

With respect to the implant systems OsseoSpeed from Dentsply-Sirona, SLA from Straumann, and TiUnite from Nobel Biocare, these belong to the most clinically documented oral implant systems in the world [2]. To remain brief, we decided to only quote five papers for each system as the total number of clinical reports on these devices amounts to several hundred scientific papers.

#### **3. Results**

### *3.1. SEM Imaging and Elemental Analysis*

Implants were analyzed in three groups. In the first group, the implant from Astra Tech–Dentsply Implants (OsseoSpeed) and the implant from Cumdente (AS Implant) were compared. The full-size

SEM image of the Astra Tech implant—digitally composed of 455 single SEM images (tiles)—showed a homogenous surface with no foreign material (Figure 3).

**Figure 3.** SEM mapping of OsseoSpeed implant (Astra Tech–Dentsply Implants). Magnification of the red marked area is shown in Figure 4.

**Figure 4.** OsseoSpeed surface: (**a**) the red marked area in Figure 3 magnified 500×; (**b**) higher magnification (2500×) of the white marked area in the left image with EDS spot analysis of an embedded TiO2-particle (spot is marked with "+" in the red circle) showing only signals of the blasting material.

Higher magnification could identify the TiO2 particles from the blasting process seen as sharp-edged particles of 5–10 mm embedded in the titanium surface. Elemental analysis of these particles only displayed signals of titanium and oxygen (Figure 4).

The Cumdente implant showed several anomalies in the correspondent full-size image, composed of 422 tiles (Figure 5).

**Figure 5.** SEM mapping of the AS Implant (Cumdente); Red marked area—see magnification in Figure 6, blue marked area—see magnification in Figure 7, green marked area—see magnification in Figure 8.

**Figure 6.** AS Implant (Cumdente) with organic particles (10–50 μm) at the implant shoulder: (**a**) systematic contamination of exposed threads, red marked area of Figure 5 in 500×; (**b**) magnification (5000×) of white marked area in the left image. The EDS differential measurement of the marked spots was identical to the particles in Figure 7.

**Figure 7.** AS Implant (Cumdente) with organic particles (5–70 μm) at the implant's apex: (**a**) blue marked area of Figure 5 in 500×; (**b**) magnification (5000×) of white marked area in Figure 7a; EDS differential measurement of marked spots is shown in Figure 8.

**Figure 8.** EDS differential measurement of the organic particle in Figure 7. Graph #1 shows titanium as the core material of this implant, with characteristic peaks at 0.452 KeV (La), 4.508 KeV (Lb), and 4.932 KeV (Kb). Graph #2 shows the spectrum of the particle with additional signals of the titanium background. The subtraction of X-ray quanta from the background material reveals the elemental composition of the impurity, which is carbon (characteristic Ka peak at 0.277 KeV) and oxygen (Ka peak at 0.523 KeV).

The SEM images with higher magnification revealed systematic contamination with multiple (>100) organic particles (5–60 μm) on exposed parts of the implant, as seen on the micro-threads next to the implant shoulder (Figure 6) and near the implant's apex (Figure 7).

In order to receive information about the particles' elemental composition, EDS measurement was performed with a spot focused on the foreign material, where background material was always detected as well, and another spot focused in direct proximity, where only the implant's core material was detected (spot #1 and #2 in Figures 6b and 7b, respectively). Using a software application, it was possible to subtract the signals of the core material so that the differential measurement revealed more precise information about the elemental composition of the foreign material. Figure 8 shows the differential EDS measurement of the particle in Figure 7, with a clear signal of carbon as the major element in this impurity.

One larger area at the implant shoulder showed numerous particles (5–40 μm) (Figure 9) with significant signals, not only of carbon but also of fluorine, as seen in the differential EDS analysis (Figure 10). The texture and elemental composition of the foreign material suggest that these particles are most likely remnants of polytetrafluoroethylene (PTFE), used at different implant production stages.

**Figure 9.** Possible remnants of polytetrafluoroethylene (PTFE), AS Implant (Cumdente); (**a**) green marked area of Figure 5 in 500× shows a larger area of impurities; (**b**) magnification (5000×) of white marked area in the left image; EDS differential measurement of the marked spots is shown in Figure 10.

**Figure 10.** EDS differential measurement of the particles in Figure 9 with significant X-ray quanta of carbon and fluorine. Note that the quantitative information provided by the EDS analysis does not always reflect the precise stoichiometric relationship of the particle's chemical elements.

The second group compared the Straumann Standard Plus SLA Tissue Level Implant with an implant of the same geometry from Bioconcept, both made of commercially pure grade 4 titanium, which is a composition of 99% titanium, 0.50% iron (maximum), oxygen 0.40% (maximum), carbon 0.085 (maximum), hydrogen 0.015% (maximum), and nitrogen 0.05% (maximum), according to the ASTM F67 specification. The SEM imaging of the Straumann implant could not detect any organic or inorganic contaminants (Figures 11 and 12).

**Figure 11.** SEM mapping, Standard Plus SLA implant (Straumann); Magnification of red marked area is shown in Figure 12.

**Figure 12.** Surface of Standard Plus SLA implant (SEM 2500×); red marked area in Figure 11 with the typical texture of a sandblasted and acid-etched titanium surface, free of foreign materials.

While the Straumann implant can be rated as clean at the micron level, the analysis of the Bioconcept implant revealed several impurities, although the full-size image showed no systematic larger contamination (Figure 13). With higher magnification, approximately 20 small organic particles (10–20 μm) were found on the implant's surface, one particle showing additional signals of sulfur (Figure 15).

**Figure 13.** SEM mapping, Tissue Level Implant (Bioconcept); red marked area—see magnification in Figure 15, blue marked area—see magnification in Figure 14.

**Figure 14.** Metal particle on the surface of the Bioconcept implant; (**a**) blue marked area in Figure 13, SEM 500×; (**b**) magnification (5000×) of white marked area in the left image (**a**) showing bright metal impurity (8 μm) and 2 points of EDS spot measurement (#1 = metal particle, #2 = core material).

Surprisingly, one metal particle of 8 μm was found on the Bioconcept implant, seemingly entirely composed of iron, as the qualitative and quantitative elemental analysis and differential measurement of this particle revealed (Figures 14 and 16).

**Figure 15.** Bioconcept implant with organic particles (10–15 μm); (**a**) red marked area in Figure 13, SEM 500×; (**b**) magnification (5000×) of white marked area in the left image (**a**); arrows indicate two embedded metal particles (0.5–1 μm) showing significant iron signals in the subsequent EDS differential measurement.

**Figure 16.** EDS differential measurement of the metal particle in Figure 14, revealing iron as the major element of the impurity.

The third group compared the NobelActive implant from Nobel Biocare with the Dental Implant from Biodenta. Both implants have an anodized surface with a characteristic titanium oxide layer. The area analysis of the NobelActive implant showed calcium and phosphorous signals in addition to titanium and oxygen. Within the scope of this analysis, neither inorganic nor organic particles were detected on the Nobel Biocare implant (Figures 17 and 18).

**Figure 17.** SEM mapping: NobelActive Internal RP implant (Nobel Biocare); red marked area—see magnification in Figure 18.

**Figure 18.** Surface of the NobelActive Internal RP implant (2500×); magnification of red marked area in Figure 17 with the typical texture of an anodized titanium surface, free of foreign materials.

While the full-size SEM image of the Biodenta implant exposed no significant organic contamination (Figure 19), the area analysis of the core material showed, in addition to calcium, phosphorous, titanium, and oxygen, high levels of magnesium in the EDS (Figure 20) that were not seen on the Nobel Biocare implant.

Significant traces of aluminum were detected in three areas of exposed threads and can be seen as bright particles (5–10 μm) in Figure 21. The graph in Figure 22 shows the correspondent EDS differential measurement of metal particles in Figure 20a.

**Figure 19.** SEM mapping: Dental Implant (Biodenta); yellow arrows indicate spots with aluminum as shown in Figure 21. Magnifications of the blue and red marked areas are shown in Figure 23.

**Figure 20.** EDS area analysis of the implant's core material (Biodenta).

**Figure 21.** Aluminum-containing particles (5–10 μm) on the surface of the Biodenta implant; location shown using yellow arrows in Figure 19; (**a**) SEM 5000× with 2 points of EDS spot measurement shown in Figure 22; (**b**) impurities with similar size in close proximity to particles shown in the left image (**a**).

**Figure 22.** EDS differential measurement of the metal particle in Figure 20 (**a**), showing significant X-ray quanta of aluminum. The lack of oxygen signals indicates that these particles were not made of aluminum oxide.

These aluminum-containing particles must be rated as inorganic impurities as they are not comparable with sharp-edged aluminum oxide particles, used for blasting procedures of other implants. Apart from this, it is noticeable that the approximately 3 μm thick oxide layer was damaged at several exposed locations of the Biodenta implant (Figure 23).

**Figure 23.** Damaged oxide layer of the Biodenta implant, SEM 1000×: (**a**) magnification of the blue marked area in Figure 19 showing the damage at the exposed implant thread; (**b**) magnification of the red marked area in Figure 19 demonstrates the large-area irregularity of the oxide layer at the implant apex.

#### *3.2. Documentation of Clinical Results*

None of the copy-cat manufacturers' websites contained any information regarding published clinical trials of the implant systems. No manufacturers responded to the email requesting scientific documentation regarding clinical performance. No manufacturers presented such documentation. The PubMed database search identified no papers regarding the Bioconcept or Cumdente system, but two papers for the Biodenta system. The two Biodenta papers were, however, in vitro trials that evaluated the company's CAD/CAM (computer-aided design/computer-aided manufacturing) system, not the clinical outcome of the implants [7,8]. Broadening the search by deleting "dental implants" and only using the respective company name did not identify any publications for the Cumdente system but one additional paper for the Biodenta system [9]. However, this paper did not report on the clinical outcome of implants. No clinical documentation of implant outcome was noticed for the Bioconcept system.

The OsseoSpeed implant has a very solid clinical documentation verifying excellent clinical results for up to 7 years in clinical function [10–14]. Similar excellent clinical results apply to the SLA implants from Straumann [4,15–18] and the TiUnite implants from Nobel Biocare [5,19–22], where these two implant systems have been documented for more than 10 years in numerous studies.

### **4. Discussion**

In general, the implants OsseoSpeed (Astra Tech–Dentsply Implants), Standard Plus SLA Implant (Straumann), and NobelActive (Nobel Biocare) showed—within the scope of this analysis—a surface free of foreign materials in the SEM. The Cumdente AS Implant with a similar geometry compared to the Astra Tech OsseoSpeed implant demonstrated a surface with substantial organic contaminants and most likely remnants of Teflon. The Straumann look-alike implant from Bioconcept exposed numerous organic particles and two small particles containing significant amounts of iron. The Nobel Biocare look-alike implant from Biodenta showed high levels of magnesium and small particles with aluminum on the surface. These particles, with a diameter of 5 to 10 μm, and organic contaminants with a similar size, are small enough for phagocytosis by macrophages that would be theoretically possible for particles without a chemical bonding to the implant surface.

It may, therefore, be said that the original implants were cleaner than the correspondent look-alike devices. The price range for the look-alike implants indicated that the definition of a copy-cat product or look-alike implant is not necessarily based on a low price.

To the knowledge of the present authors, no defined thresholds have been published in peer reviewed journals until now, with respect to what may represent "acceptable" levels of impurities and what must be regarded as "unacceptable impurities". However, the non-profit CleanImplant Foundation (www.cleanimplant.org) has presented a consensus statement on surface impurities signed by Luigi Canullo (Rome, Italy), Jaafar Mouhyi (Marrakesh, Morroco), Michael Norton (London, UK), and four of the authors of this paper Tomas Albrektsson, Florian Beuer, Dirk Duddeck, and Ann Wennerberg [23]. In this consensus statement, surface anomalies and remnants of blasting materials were not considered clinically relevant, in contrast to the metal particles of tungsten, nickel, iron, chromium, copper, tin or antimony found on the surfaces of some implants. Single organic particles smaller than 50 μm in diameter were considered less vicious than numerous particles, with a maximum of 30 particles along the circumference of the implant. Major plaque-like organic contaminants exceeding the size of 50 μm and PTFE particles, presumably originating from Teflon baskets used during implant production, were considered unacceptable.

Other foreign bodies routinely seen adjacent to implants such as titanium particles [24–26] or the accidental presence of cement in the bone-to-implant interface that, according to some investigators, may be found in 59% of cemented implants [27], may combine to cause peri-implantitis [28].

Impurities on sterile packaged implants—caused by metal particles and contaminations with organic substances such as thermoplastic materials, synthetic polymers, or polysiloxanes—are technically avoidable, as this paper demonstrated. The academic discussion as to what extent implant pollution is acceptable normally ends quickly when dental professionals know about such contamination of an implant system and the next patient for an implant therapy is their partner or child. We should avoid using sterile packaged implants with verifiable impurities and therewith follow the well-established "precautionary principle" as an evolution of the ancient medical principle of "primum non nocere".

From a clinical point of view, it is obvious that Astra Tech–Dentsply Implants, Straumann, and Nobel Biocare have solidly documented clinical results reported in hundreds of scientific papers. On the other hand, a long history of clinical documentation representing high-quality efforts in the past is no guarantee for a high level of production quality and a clean surface at present, accentuating the need for periodic reviews by independent institutions. With respect to the look-alike systems, none of them had any properly documented clinical reports available. The absence of clinical documentation of look-alike systems may indicate either that they see themselves as identical to the implants they have copied or that they see implants as commodity products where all implant systems will work well clinically. The possibility first mentioned was critically analyzed in this paper comparing the cleanliness of different implant systems. The second possibility that implants are commodity products may be criticized against the knowledge of numerous implant systems that have been withdrawn from the market due to the unforeseen clinical problems over longer times of follow-up [29].

In essence, our hypothesis was verified in that the major implant systems displayed cleaner surfaces than those of their respective look-alike implants. However, whether the relative lack of cleanliness of look-alike implants indicates that they have an impaired clinical function in comparison to the major systems remains uncertain. Having said this, oral implants are placed in human beings and, therefore, it seems strongly advisable to present clinical results in peer-reviewed journals for every oral implant system to be used clinically. In this regard, the look-alike implants are clearly inferior to the major documented oral implant systems and none of the look-alike systems investigated had any clinical documentation of their own, which must be regarded as a major shortcoming. Since differences obviously exist between the major systems and the respective look-alike implants, clinicians using the latter devices must inform their patients of this fact and that the implants placed are totally un-documented with respect to clinical outcome.

#### **5. Conclusions**

In contrast to the original implants of market-leading manufacturers, the analyzed look-alike implants showed significantly more impurities, underlining the need for periodic reviews of the production quality by independent institutions. Multiple organic particles and remnants of PTFE (Cumdente), organic particles containing sulfur, particles containing iron (Bioconcept) or impurities with aluminum (Biodenta)—all particles small enough for possible phagocytosis—expose patients to unknown risks. In addition to the results of SEM/EDS analysis, the lack of clinical documentation of the analyzed look-alike implants raises concerns.

**Author Contributions:** Conceptualization, D.U.D., A.W., and T.A.; Investigation, D.U.D., C.L., and A.W.; Resources, D.U.D.; Writing—Original Draft Preparation, D.U.D., T.A., A.W., and C.L., Writing—Review and Editing, A.W., C.L., and F.B.; Supervision, D.U.D.; Project Administration, D.U.D.

**Funding:** This research received no external funding.

**Acknowledgments:** SEM images and elemental analyses for this paper were performed with technical support from the Medical Materials Research Institute–mmri.berlin, Max-Planck-Str. 3, Zentrum für Mikrosysteme und Materialien (ZMM), 12489 Berlin–Adlershof, Germany.

**Conflicts of Interest:** Tomas Albrektsson is a scientific consultant to Nobel Biocare. All other authors declare no conflict of interest.

#### **References**


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