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 t...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-04-01
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| Series: | Head & Face Medicine |
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| Online Access: | https://doi.org/10.1186/s13005-024-00426-0 |
| _version_ | 1797199117287424000 |
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| author | Mark Adam Antal Ramóna Kiscsatári Gábor Braunitzer József Piffkó Endre Varga Noam Eliaz |
| author_facet | Mark Adam Antal Ramóna Kiscsatári Gábor Braunitzer József Piffkó Endre Varga Noam Eliaz |
| author_sort | Mark Adam Antal |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T07:10:39Z |
| format | Article |
| id | doaj.art-47ac6596968f470ca8d77c414bef54e5 |
| institution | Directory Open Access Journal |
| issn | 1746-160X |
| language | English |
| last_indexed | 2024-04-24T07:10:39Z |
| publishDate | 2024-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Head & Face Medicine |
| spelling | doaj.art-47ac6596968f470ca8d77c414bef54e52024-04-21T11:31:36ZengBMCHead & Face Medicine1746-160X2024-04-0120111410.1186/s13005-024-00426-0Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trialMark Adam Antal0Ramóna Kiscsatári1Gábor Braunitzer2József Piffkó3Endre Varga4Noam Eliaz5Department of Operative and Esthetic Dentistry, Faculty of Dentistry, University of SzegedDepartment of Oral and Maxillofacial Surgery, Faculty of Medicine, University of SzegeddicomLAB Dental, LtdDepartment of Oral and Maxillofacial Surgery, Faculty of Medicine, University of SzegeddicomLAB Dental, LtdDepartment of Materials Science and Engineering, Tel-Aviv UniversityAbstract 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.https://doi.org/10.1186/s13005-024-00426-0Dental implantSurface treatmentOsseointegrationRFAHydroxyapatite |
| spellingShingle | Mark Adam Antal Ramóna Kiscsatári Gábor Braunitzer József Piffkó Endre Varga Noam Eliaz Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial Head & Face Medicine Dental implant Surface treatment Osseointegration RFA Hydroxyapatite |
| title | Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial |
| title_full | Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial |
| title_fullStr | Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial |
| title_full_unstemmed | Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial |
| title_short | Assessment of a novel electrochemically deposited smart bioactive trabecular coating (SBTC®): a randomized controlled clinical trial |
| title_sort | assessment of a novel electrochemically deposited smart bioactive trabecular coating sbtc r a randomized controlled clinical trial |
| topic | Dental implant Surface treatment Osseointegration RFA Hydroxyapatite |
| url | https://doi.org/10.1186/s13005-024-00426-0 |
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