About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Extracted human teeth obtained for reasons unrelated to this study (e.g., orthodontic or periodontal indications).
Teeth collected after obtaining ethical approval from the Research Ethics Committee.
Teeth free from visible cracks, fractures, restorations, or developmental defects.
Disqualifiers
- Teeth with caries, restorations, cracks, fractures, or structural defects.
Teeth extracted due to pathological conditions affecting enamel or dentin integrity.
Teeth with unknown extraction history
Trial design
Parallel
Treatments tested in this trial
Modified 3D-Printed Orthodontic Aligner Resin
Other interventionDirectly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Treatment groups
Trial outcomes
Primary outcomes
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
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).
Ion Release from Modified Aligner Resin
Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)
Secondary outcomes
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.
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
Shape Memory
Assessment of shape recovery rate (%) Unit of Measure: % (recovery)
Water Sorption and Solubility
Measurement of water sorption and solubility according to ISO 20795-1. Unit of Measure: µg/mm³
Sponsors and contacts
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