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

NCT07603427 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-22

No results posted yet for this study

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

Conditions

  • Orthodontic Aligner Material
  • Enamel Demineralization
  • Dental Biofilm Formation
  • Clear Aligner Material Properties

Interventions

OTHER

Modified 3D-Printed Orthodontic Aligner Resin

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

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Principal Investigators

  • Ali I Ibrahim, Prof. Dr · University of Baghdad

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-12-01
Completion
2027-02-01

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603427 on ClinicalTrials.gov