College of Dentistry, University of Baghdad
Baghdad, Baghdad Governorate, 1417, Iraq
Not Yet Recruiting
NCT Number: NCT07603427
Development of Biofunctional 3D-Printed Orthodontic Aligners With Antimicrobial and Remineralizing Properties
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
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Modified 3D-Printed Orthodontic Aligner Resin
OtherDirectly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Primary outcomes
-
Antimicrobial Activity of Modified 3D-Printed Aligner Resin
Time frame: day 1
Evaluation of antibacterial effectiveness by quantifying Streptococcus mutans biofilm using colony-forming unit (CFU) counts (CFU/mL
-
Enamel Remineralization Assessed by Raman Spectroscopy
Time frame: day 7
Assessment of mineral content changes in enamel adjacent to aligner material using Raman spectroscopy (e.g., phosphate ν1 peak intensity at ~960 cm-¹).
-
Ion Release from Modified Aligner Resin
Time frame: day 7
Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)
Secondary outcomes
-
Tensile Properties of Modified 3D-Printed Aligner Resin
Time frame: After specimen fabrication and post-curing (Day 1)
Assessment of tensile strength and elastic modulus of unmodified and modified aligner resins according to ISO 527-2.Unit of Measure: MPa.
-
Flexural Properties of Modified 3D-Printed Aligner Resin
Time frame: (Day 1)
Evaluation of flexural strength and flexural modulus using a three-point bending test.Unit of Measure: MPa
-
Shape Memory
Time frame: day 1
Assessment of shape recovery rate (%) Unit of Measure: % (recovery)
-
Water Sorption and Solubility
Time frame: day 1 to day 7
Measurement of water sorption and solubility according to ISO 20795-1. Unit of Measure: µg/mm³
-
Optical Properties: Translucency
Time frame: day 1
Evaluation of translucency parameter (TP) using spectrophotometric analysis. Unit of Measure: Translucency Parameter (TP)
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Baghdad
Other
Registry information
Official study title
Development of Biofunctional 3D Printed Orthodontic Aligners Enriched With Remineralizing and Anti-microbial Agents
Acronym: 3D-BIOALIGN
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- May 22, 2026
- Registry last updated
- May 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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