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

Development of Biofunctional 3D Printed Orthodontic Aligners Enriched With Remineralizing and Anti-microbial Agents

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

Study Overview

• Status: Not yet recruiting
• Conditions: Enamel Demineralization; Orthodontic Aligner Material; Dental Biofilm Formation; Clear Aligner Material Properties
• Intervention / Treatment: Other: Modified 3D-Printed Orthodontic Aligner Resin

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Safaa Saud Abed; Phone Number: 009647712375540; Email: safaasaud83@gmail.com
• Study Contact Backup: Name: Ali I Ibrahim; Email: ali.ibrahim@kcl.ac.uk

Study Locations

• Iraq
  • Baghdad Governorate
    • Baghdad, Baghdad Governorate, Iraq, 1417
      • College of Dentistry, University of Baghdad
      • Contact: Ali I Ibrahim, professor of orthodontics; Phone Number: 00964 7705814633; Email: ali.ibrahim@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control group; Directly 3D-printed orthodontic aligner resin	Other: Modified 3D-Printed Orthodontic Aligner Resin; Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Experimental: DMAHDM group; Directly 3D-printed orthodontic aligner resin with incorporation of dimethylaminohexadecyl methacrylate (DMAHDM)	Other: Modified 3D-Printed Orthodontic Aligner Resin; Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Experimental: ACP group; Directly 3D-printed orthodontic aligner resin with incorporation of Amorphous calcium phosphate (ACP)	Other: Modified 3D-Printed Orthodontic Aligner Resin; Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Experimental: DMAHDM + ACP group; Directly 3D-printed orthodontic aligner resin with incorporation both DMAHDM and ACP	Other: Modified 3D-Printed Orthodontic Aligner Resin; Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After specimen fabrication and post-curing (Day 1)
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	(Day 1)
Shape Memory	Assessment of shape recovery rate (%) Unit of Measure: % (recovery)	day 1
Water Sorption and Solubility	Measurement of water sorption and solubility according to ISO 20795-1. Unit of Measure: µg/mm³	day 1 to day 7
Optical Properties: Translucency	Evaluation of translucency parameter (TP) using spectrophotometric analysis. Unit of Measure: Translucency Parameter (TP)	day 1

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Study Chair: Ali I Ibrahim, Prof. Dr, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: May 15, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1161426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: participants confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No