From manufacturers to clinicians, the release of dental implant particles can no longer be ignored
Bibliographic record
Abstract
What is knownThere is increasing evidence that titanium-based dental implant complications are associated with the release of metallic elements.Many clinicians remain unconcerned about such issue, and there is currently no international standards for the evaluation of biological response to implant wear particles. What this study addsThis opinion article provides a concise summary of the current evidence and shortcomings in the field, with the aim to raise awareness among dental implant providers.Dental implants offer a widely accepted and viable long-term treatment option for patients with missing teeth.1,2 Since the discovery of its biocompatibility and capability of osseointegration, titanium (Ti) and its alloys have become the gold standard and most widely used in implant dentistry.3,4 There are implants made with other materials, this opinion paper will focus on titanium-based implants.While such implants have proven to be highly reliable and have high success rates, it is not without complications.Some implants fail due to a variety of reasons including peri-implantitis, lack of osseointegration, material wear and corrosion, and hypersensitivity.[5][6][7] For any implant system on the market, a series of complex and stringent standards need to be met during various stages including in vitro testing, in vivo and clinical trials, and manufacturing.Table 1 summarises the major standards dental implant companies follow.Authors searched publicly available compliance documentations published by major dental implant companies, including BioHorizons, Dentsply Sirona, Nobel Biocare, Osstem, and Straumann.While all companies demonstrated compliance with ISO 13485 (Medical device quality management system) during the design, development, manufacture, and distribution of dental implants (and related components), information on how tests were conducted in accordance to abovementioned ISO standards was not readily available to public.In addition, standards for biological evaluation of medical devices such as ISO 10993 permits the use of whole implant, and thus the biological implications of free Ti-based particles and metallic ions can be overlooked.In patients that had dental implants, Ti particles, as a product of wear and/or degradation, have been detected in both intra-and extra-oral tissues.Ti particles have been found in peri-implant bone and/or soft tissues, submucosal plaque, and in distant lymph nodes in human pilot studies.[13][14][15] Ti particles have also been shown in both Fadi N. Barrak and Siwei Li contributed equally to this study.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.062 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.002 | 0.004 |
| Scholarly communication | 0.016 | 0.015 |
| Open science | 0.002 | 0.005 |
| Research integrity | 0.013 | 0.010 |
| Insufficient payload (model declined to judge) | 0.063 | 0.082 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".