Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial

Abstract

Objectives: A randomized controlled clinical trial of dental implants was conducted to compare the clinical properties of a novel electrochemically deposited calcium phosphate coating to those of a common marketed surface treatment.

Material and methods: Forty implants of the same brand and type were placed in 20 fully edentulous participants requiring mandibular implantation. The two study groups were defined by the surface treatment of the implants. 20 implants in the control group were coated via a commercial electrochemical surface treatment that forms a mixture of brushite and hydroxyapatite, while the remaining 20 in the test group were coated with a novel electrochemical Smart Bioactive Trabecular Coating (SBTC®). A split-mouth design was employed, with each participants receiving one control implant in one mandibular side and a test implant in the other. To mitigate potential operator-handedness bias, control and test implants were randomly assigned to mandibular sides. All cases underwent digital planning, implant placement with a static surgical guide, and participants received locator-anchored full-arch dentures. The primary outcome was implant stability (measured using Osstell ISQ) assessed at insertion, loading, and then 3 months, 9 months, and 2 years post-insertion. The secondary outcome was bone level change (in millimeters) over the 2-year observation period. Oral health-related quality of life (OHRQL) was monitored using the OHIP-14 questionnaire. Complications and adverse events were recorded.

Results: Successful osseointegration and implant stability were achieved in all cases, allowing loading. ISQ values steadily increased throughout the observation period. While no significant differences were observed between the SBTC® and control coatings, the test group exhibited a higher ISQ gain. Bone resorption was somewhat lower in the SBTC® but not significantly so. Patients' OHRQL significantly improved after denture delivery and remained stable throughout the follow-up. No complications or adverse events were observed.

Conclusions: Based on the study results, we conclude that the new surface treatment is a safe alternative to the widely used control surface, demonstrating similar osseointegrative properties and time-dependent bone level changes. Further research may explore the broader implications of these findings.

Trial registration: The study is registered on clinicaltrials.gov under the identifier ID: NCT06034171.

Keywords: Dental implant; Hydroxyapatite; Osseointegration; RFA; Surface treatment.

Fig. 1

CONSORT flowchart. Asterisk (*) indicates that Osstell ISQ measurements were not performed in all visits in the interim visits period, only at 9 months after insertion, which falls into this period. OHRQL: Oral health-related quality of life (OHIP-14 questionnaire). The flowchart was generated using Lucidchart (Lucid Software, Inc., USA)

Fig. 2

A boxplot summary of the ISQ results by study group (BL direction). Circles indicate outliers, stars indicate extreme outliers

Fig. 3

A boxplot summary of the ISQ results by study group (MD direction). Circles indicate outliers, stars indicate extreme outliers

Fig.4

Scanning electron microscopic images of the test surface (SBTC) at 50x (a), 1000x (b), 2000x (c) and 5000x (d) magnification. Surface coverage between threads (a) and needle-like surface morphology (b-d) of the SBTC® coating. The scanned implant was from the same series as implanted in the participants

Fig.5

Scanning electron microscopic images of the control surface at 50x (a), 1000x (b), 2000x (c) and 5000x (d) magnification. Surface coverage between threads (a) and platelet-like surface morphology (b-d) of the reference (control) coating. The scanned implant was from the same series as implanted in the participants