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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Modified 3D-Printed Orthodontic Aligner Resin

    Other intervention

    Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: control groupExperimental treatment 1 intervention
Group B: DMAHDM groupExperimental treatment 1 intervention
Group C: ACP groupExperimental treatment 1 intervention
Group D: DMAHDM + ACP groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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)
2

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)
3

Shape Memory

Assessment of shape recovery rate (%) Unit of Measure: % (recovery)

Time frame
day 1
4

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

Other outcomes

Sponsors and contacts

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