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Osseointegration of a novel injection molded 2-piece ceramic dental implant: a study in minipigs

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Abstract

Objectives

This study compared the osseointegrative potential of a novel injection molded zirconia dental implant (Neodent Zi ceramic implant, test) and a commercially available titanium implant (Neodent Alvim implant, control) in terms of histomorphometrically derived bone-to-implant contact (BIC), first bone-to-implant contact (fBIC), and the ratio of bone area to total area (BATA) around the implant.

Materials and methods

A total of 36 implants, 18 per individual test device, were implanted in a split-mouth arrangement in either side of the edentulous and fully healed mandible of 6 minipigs. Histomorphometric analysis of BIC, fBIC, and BATA were performed 8 weeks post implantation and subjected to statistical non-inferiority testing. Surface characteristics of both implant types were compared in terms of contact angle, surface topography, and elemental composition.

Results

BIC, fBIC, and coronal BATA values of test and control implants were statistically comparable and non-inferior. BIC values of 77.8 ± 6.9% vs. 80.7 ± 6.9% (p = 0.095) were measured for the test and control groups. fBIC lingual values were − 238 ± 328 μm compared with − 414 ± 511 μm (p = 0.121) while buccal values were − 429 ± 648 μm and − 588 ± 550 μm (p = 0.230) for the test and control devices, respectively. BATA in the apical segment was significantly higher in the test group compared with the control group (67.2 ± 11.8% vs. 59.1 ± 11.4%) (p = 0.0103). Surface topographies of both implant types were comparable. Surface chemical analysis indicated the presence of carbonaceous adsorbates which correlated with a comparable and predominantly hydrophobic character of the implants.

Conclusion

The results demonstrate that the investigated zirconia implants, when compared with a commercially available titanium implant, show equivalent and non-inferior bone integration, bone formation, and alveolar bone level maintenance. This qualifies the investigated zirconia implant as a potential candidate for clinical development.

Clinical relevance

This study investigated the osseointegration of a novel zirconia 2-piece dental implant prototype intended for clinical development. With the aim of translating this prototype into clinical development preclinical models, procedures and materials within this study have been selected as close to clinical practice and human physiological conditions as possible.

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Acknowledgments

The authors would like to thank Letitia Grace from the Swiss Tropical Institute (Basel) for the support of the statistical analysis and Novonexile AG (Switzerland) for the writing assistance and editorial support in the preparation of the manuscript.

Funding

This research was financially supported by Neodent and Straumann. Neodent is a daughter company of Straumann. This work may potentially lead to the development of products, in which Neodent and Straumann may have a business and/or financial interest. Neodent and Straumann therefore may be affected by the research reported in the enclosed paper.

Author information

Authors and Affiliations

  1. Neodent, Curitiba, Brazil

    Geninho Thomé, Sergio Bernardes & Larissa Trojan

  2. Biomedical Center, Faculty of Medicine, Lund University, Lund, Sweden

    Rebecca Sandgren

  3. AnaPath AG, Liestal, Switzerland

    Nils Warfving

  4. Department of Preclinical and Translational Research, Institut Straumann AG, Peter Merian-Weg 12, 4052, Basel, Switzerland

    Benjamin Bellón & Benjamin E. Pippenger

  5. Department of Periodontology, Faculty of Dentistry, University of Zurich, Zurich, Switzerland

    Benjamin Bellón & Benjamin E. Pippenger

Authors
  1. Geninho Thomé
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  2. Rebecca Sandgren
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  4. Larissa Trojan
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  7. Benjamin E. Pippenger
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Corresponding author

Correspondence to Benjamin E. Pippenger.

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Conflict of interest

Dr. Geninho Thomé declares that he is an employee of Neodent. Mrs. Rebecca Sandgren declares that she has no conflict of interest. Dr. Sergio Bernardes declares that he is an employee of Neodent. Dr. Larissa Trojan declares that she is an employee of Neodent. Dr. Nils Warfving declares that he has no conflict of interest. Dr. Benjamin Pippenger declares that he is an employee of Straumann. Mr. Benjamin Bellón declares that he is an employee of Straumann.

Ethical approval

This article does not contain any studies with human participants performed by any of the authors. Ethical standards related to the research of human subjects are not applicable. All applicable international, national, and/or institutional guidelines for the care and use of animals were followed. This study was conducted at the Biomedical Department of Lund University (Sweden) and approved by the local ethics committee of the university (M-192-14). The study was conducted in accordance with ISO 10993-6 “Biological evaluation of medical devices – Part 6 Tests for local effects after implantation guideline and recommendations.” This study adheres to the ARRIVE guidelines.

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Thomé, G., Sandgren, R., Bernardes, S. et al. Osseointegration of a novel injection molded 2-piece ceramic dental implant: a study in minipigs. Clin Oral Invest 25, 603–615 (2021). https://doi.org/10.1007/s00784-020-03513-z

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  • DOI: https://doi.org/10.1007/s00784-020-03513-z

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