Clear Aligner Material Properties, Dental Biofilm Formation, Enamel Demineralization, Orthodontic Aligner Material
Conditions
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
Interventions
OTHERModified 3D-Printed Orthodontic Aligner Resin
Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Sponsors
University of Baghdad
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel experimental groups comparing unmodified and modified 3D-printed orthodontic aligner materials
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial Activity of Modified 3D-Printed Aligner Resin | 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 | 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 | day 7 | Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tensile Properties of Modified 3D-Printed Aligner Resin | 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 | (Day 1) | Evaluation of flexural strength and flexural modulus using a three-point bending test.Unit of Measure: MPa |
| Shape Memory | day 1 | Assessment of shape recovery rate (%) Unit of Measure: % (recovery) |
| Water Sorption and Solubility | day 1 to day 7 | Measurement of water sorption and solubility according to ISO 20795-1. Unit of Measure: µg/mm³ |
| Optical Properties: Translucency | day 1 | Evaluation of translucency parameter (TP) using spectrophotometric analysis. Unit of Measure: Translucency Parameter (TP) |
Countries
Iraq
Contacts
CONTACTSafaa Saud Abed
CONTACTAli I Ibrahim
STUDY_CHAIRAli I Ibrahim, Prof. Dr
University of Baghdad
Outcome results
None listed