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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Baghdad

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

Qualifiers

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

Treatments tested in this trial

  • Modified 3D-Printed Orthodontic Aligner Resin

Treatment groups

400 Participants
are divided into 4 treatment groups

Sponsors and collaborators