Comparison of 3D Printed Metal Fixed Retainer Versus Conventional Fixed Bonded Retainer
ClinicalTrials.gov Studies
Summary
NIH ClinicalTrials.gov registered a new randomized controlled trial (NCT07538869) comparing 3D-printed metal fixed retainers against conventional fixed bonded retainers in dental/orthodontic patients. The study will evaluate bond failure outcomes at immediate and 12-month timepoints, addressing a gap in long-term clinical evidence for titanium and 3D-printed retainer materials. Conditions under study are bond and pair; the trial is registered with an anticipated update date of April 20, 2026.
What changed
NIH ClinicalTrials.gov added a new study registration entry (NCT07538869) for a randomized controlled trial evaluating 3D-printed metal fixed retainers versus conventional fixed bonded retainers in orthodontic treatment. The study focuses on bond failure as the primary condition and includes both intervention arms: a 3D-printed metal fixed retainer and a conventional fixed retainer. This registration documents the trial design but does not impose compliance obligations on regulated entities.
Affected parties include clinical investigators, dental/orthodontic research institutions, and manufacturers of 3D-printed dental devices. Sponsors conducting similar comparative effectiveness research in dental devices should ensure their trial registrations on ClinicalTrials.gov are current and reflect interim and 12-month outcome measures. The evidence generated by this trial may inform future FDA 510(k) submissions or predicate-device comparisons for 3D-printed orthodontic retainers.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Comparison of 3D Printed Metal Fixed Retainer Versus Conventional Fixed Bonded Retainer
N/A NCT07538869 Kind: NA Apr 20, 2026
Abstract
Despite the growing diversity of materials used for mandibular fixed retainers, the evidence base remains inconclusive. In particular, conflicting findings have been reported regarding the bond failure of titanium retainers across different evaluation periods, including immediate and 12-month outcomes. Additionally, the emergence of 3D metal-printed retainers has not yet been matched by sufficient clinical evidence, with current data being limited and lacking long-term validation.
Conditions: Bond, Pair
Interventions: bar 3d printed metal fixed retainer, conventional fixed retainer
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