Metal‐Free Custom‐Made Zirconia Implants—A Prospective 5‐Year Follow‐Up Single‐Arm Clinical Trial
Bibliographic record
Abstract
ABSTRACT Background Dental implants made of zirconia (ZrO 2 ) are a potential alternative for titanium implants in dentistry because of their good biocompatibility, mechanical properties and excellent aesthetic results. However, solid long‐term scientific data to prove clinical success of ZrO 2 implants are scarce. Aim The aim of this study was to describe and to examine the clinical performance of custom‐made two‐piece ZrO 2 implants, to identify possible influencing factors: a) manipulation of the implant after placement and b) the occlusal scheme on the survival rate, and to evaluate the performance of the implant‐supported crown. This follow‐up study collected and examined the 5‐year data to answer the main question: What are the survival and the success rates of custom‐made ZrO 2 implants in the maxillary premolar region after 5 years? Material and Methods Of the 31 included patients in this prospective 5‐year follow‐up single‐arm clinical trial, 30 received a custom‐made ZrO 2 implant to replace a missing single maxillary premolar, which was subsequently restored with a lithium disilicate crown. Parameters regarding clinical performance, marginal bone‐level (MBL) changes, and patient‐related outcome measures (PROMs) were assessed preoperatively, at the baseline, as well as 1 and 5 years after crown placement. Chances of survival and success of the implant were calculated and displayed using Kaplan–Meier statistics. Kaplan–Meier survival analysis was also performed with stratification based on the variables “manipulation of the implant prior to impression taking” and “occlusal scheme” and compared using log‐rank tests. Bone‐level moderation in time was compared using a paired samples t ‐test. Patient's expectations and satisfaction after 5 years were compared as a measure of fulfilled expectations, using a Wilcoxon signed‐rank test. Performance of the implant‐supported crowns was evaluated using validated criteria. Results Survival and success probabilities after 5 years were, respectively, 75.8% (95% CI [60.0%; 91.0%]) and 71.0% (95% CI [54.0%; 88.0%]) for the custom‐made ZV3 implants. No significant differences in survival rate were found after stratification on “manipulation of the implant” and on “occlusal scheme.” Mean bone‐level alteration between baseline and the first follow‐up was +0.06 mm (95% CI [−0.23 mm; 0.12 mm]; SD = 0.42 mm) and between baseline and the second follow‐up was +0.04 mm (95% CI [−0.35 mm; 0.26 mm]; SD = 0.54 mm). Patients' satisfaction for patients with implants still in function after 5 years was 91.7% (IQR = [90.5%–97.3%]), indicating satisfaction with the treatment. Pooled satisfaction in patients with successful implants after 5 years was significantly higher than patients' expressed expectations before treatment. None of the crowns failed, and no interventions were required. Conclusion and Clinical Implications Survival rate of these particular ZV3 implants in our study was lower than expected and clinically not acceptable. Hence, ZV3 implant placement as applied in this study cannot be recommended for clinical practice. Further research on the different appearances of mechanical failure in ZrO 2 implants would be highly recommended before a larger prospective randomized clinical trial is conducted to evaluate treatment with custom‐made ZrO 2 dental implants.
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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 | 0.006 | 0.002 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
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".