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

NCT07603427 | Not Yet Recruiting

• 1 other identifier: 1161426
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

  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).

  day 7

• Ion Release from Modified Aligner Resin

  Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)

  day 7

Secondary Outcomes (5)

• Tensile Properties of Modified 3D-Printed Aligner Resin

  After specimen fabrication and post-curing (Day 1)

• Flexural Properties of Modified 3D-Printed Aligner Resin

  (Day 1)

• Shape Memory

  day 1

• Water Sorption and Solubility

  day 1 to day 7

• Optical Properties: Translucency

  day 1

Study Arms (4)

control group

EXPERIMENTAL

Directly 3D-printed orthodontic aligner resin

Other: Modified 3D-Printed Orthodontic Aligner Resin

DMAHDM group

EXPERIMENTAL

Directly 3D-printed orthodontic aligner resin with incorporation of dimethylaminohexadecyl methacrylate (DMAHDM)

Other: Modified 3D-Printed Orthodontic Aligner Resin

ACP group

EXPERIMENTAL

Directly 3D-printed orthodontic aligner resin with incorporation of Amorphous calcium phosphate (ACP)

Other: Modified 3D-Printed Orthodontic Aligner Resin

DMAHDM + ACP group

EXPERIMENTAL

Directly 3D-printed orthodontic aligner resin with incorporation both DMAHDM and ACP

Other: Modified 3D-Printed Orthodontic Aligner Resin

Interventions

Modified 3D-Printed Orthodontic Aligner Resin OTHER

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

ACP group; DMAHDM + ACP group; DMAHDM group; control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Baghdad Governorate, 1417, Iraq

Location

Study Officials

• Ali I Ibrahim, Prof. Dr

  University of Baghdad

  STUDY CHAIR

Central Study Contacts

Safaa Saud Abed

CONTACT

009647712375540; safaasaud83@gmail.com

Ali I Ibrahim

CONTACT

ali.ibrahim@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate/PhD student

Model Details: Parallel experimental groups comparing unmodified and modified 3D-printed orthodontic aligner materials

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)