An interventional study of Modified 3D-Printed Orthodontic Aligner Resin in Orthodontic Aligner Material, Enamel Demineralization and Dental Biofilm Formation, sponsored by University of Baghdad. Not yet recruiting at 1 site in Iraq. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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
University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Directly 3D-printed orthodontic aligner resin
Other: Modified 3D-Printed Orthodontic Aligner Resin
Directly 3D-printed orthodontic aligner resin with incorporation of dimethylaminohexadecyl methacrylate (DMAHDM)
Other: Modified 3D-Printed Orthodontic Aligner Resin
Directly 3D-printed orthodontic aligner resin with incorporation of Amorphous calcium phosphate (ACP)
Other: Modified 3D-Printed Orthodontic Aligner Resin
Directly 3D-printed orthodontic aligner resin with incorporation both DMAHDM and ACP
Other: Modified 3D-Printed Orthodontic Aligner Resin
Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Antimicrobial Activity of Modified 3D-Printed Aligner Resin
Evaluation of antibacterial effectiveness by quantifying Streptococcus mutans biofilm using colony-forming unit (CFU) counts (CFU/mL
Time frame: day 1
Enamel Remineralization Assessed by Raman Spectroscopy
Assessment of mineral content changes in enamel adjacent to aligner material using Raman spectroscopy (e.g., phosphate ν1 peak intensity at \~960 cm-¹).
Time frame: day 7
Ion Release from Modified Aligner Resin
Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)
Time frame: day 7
Tensile Properties of Modified 3D-Printed Aligner Resin
Assessment of tensile strength and elastic modulus of unmodified and modified aligner resins according to ISO 527-2.Unit of Measure: MPa.
Time frame: After specimen fabrication and post-curing (Day 1)
Flexural Properties of Modified 3D-Printed Aligner Resin
Evaluation of flexural strength and flexural modulus using a three-point bending test.Unit of Measure: MPa
Time frame: (Day 1)
Shape Memory
Assessment of shape recovery rate (%) Unit of Measure: % (recovery)
Time frame: day 1
Water Sorption and Solubility
Measurement of water sorption and solubility according to ISO 20795-1. Unit of Measure: µg/mm³
Time frame: day 1 to day 7
Optical Properties: Translucency
Evaluation of translucency parameter (TP) using spectrophotometric analysis. Unit of Measure: Translucency Parameter (TP)
Time frame: day 1
Plan to share: No — participants confidentiality
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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