Clinical Trial

Development of Biofunctional 3D-Printed Orthodontic Aligners With Antimicrobial and Remineralizing Properties

Study acronym: 3D-BIOALIGN
Not Yet Recruiting
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Summary
Clear orthodontic aligners are widely used due to their esthetics and patient comfort; however, prolonged wear may promote biofilm accumulation and enamel demineralization. This laboratory-based (in vitro) study aims to develop and evaluate a novel directly 3D-printed orthodontic aligner resin modified with antimicrobial and remineralizing agents. The study will investigate the incorporation of dimethylaminohexadecyl methacrylate (DMAHDM) as an antibacterial agent and amorphous calcium phosphate (ACP) as a remineralizing component into a 3D-printed aligner resin. Modified and unmodified resin specimens will be fabricated and assessed for antimicrobial activity, ion release, and enamel remineralization potential using extracted human teeth. In addition, the mechanical and physical properties of the experimental aligner materials, including shape memory behavior, deflection, tensile strength, translucency, and water sorption, will be evaluated to ensure clinical suitability. This study does not involve human participants and is conducted entirely in vitro. The findings are expected to contribute to the development of biofunctional orthodontic aligners that actively inhibit bacterial growth and support enamel health without compromising material performance
Trial Details
NCT Number NCT07603427
Lead Sponsor University of Baghdad
Conditions Orthodontic Aligner Material, Enamel Demineralization, Dental Biofilm Formation, Clear Aligner Material Properties
Enrollment 400 participants
Start Date 2026-06-01
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22