AI Article Synopsis
- The study compared the OsseoSpeed control implant with a modified version called OsseoSpeed TX, focusing on marginal bone levels and implant survival after one year.
- A total of 92 subjects received either implant type in a randomized controlled trial, and both groups showed similar bone level alterations and cumulative survival rates.
- The findings indicated that the design change did not significantly impact the clinical outcomes, though some variability in data may have affected results.
Article Abstract
Unlabelled: The design of the commercially available implant OsseoSpeed (control) was changed to a tapered apex with a smaller apical diameter; OsseoSpeed TX (test).
Objective: The present study evaluated the clinical outcome of marginal bone level as primary outcome, and cumulative implant survival rate, primary stability and condition of the peri-implant mucosa as secondary outcomes, one year after loading.
Material And Methods: 92 subjects (150 implants, ten centres), with partially or totally edentate maxillae were randomized to receive either test or control implants. One to six implants were placed in each subject using a one-stage surgical procedure. Subjects received a permanent prosthesis 10-12 weeks after implant placement and were followed for one year.
Results: 47 subjects in the test group received 82 implants and 45 subjects in the control group received 68 implants. Marginal bone level alterations from loading to 1-year follow-up was -0.02 × 0.41 mm (mean × SD) and -0.03 × 0.38 mm (mean × SD) for the test and the control group, respectively, indicating no difference between the groups. Non-inferiority was declared as confidence interval for the difference between control and test implants was no worse than 0.5 mm. The CSR was 98.8% in the test group and 100% in the control group, with no statistically significant difference between the groups.
Conclusions: Change of the apical design of a commercially available implant showed no significant effect on marginal bone level and CSR compared to the control implant. Missing data and many investigators may have influenced on the result. NCT01324778.
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| http://dx.doi.org/10.1080/00016357.2021.1894352 | DOI Listing |
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