Development of Biofunctional 3D-Printed Orthodontic Aligners With Antimicrobial and Remineralizing Properties
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Modified 3D-Printed Orthodontic Aligner Resin.
- Who it may be relevant to
- Registry conditions: Orthodontic Aligner Material, Enamel Demineralization, Dental Biofilm Formation, Clear Aligner Material Properties. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Iraq
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Biofunctional 3D Printed Orthodontic Aligners Enriched With Remineralizing and Anti-microbial Agents
Overview
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
- Other Modified 3D-Printed Orthodontic Aligner Resin
Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
Primary outcome measures
- Antimicrobial Activity of Modified 3D-Printed Aligner Resin [Time frame: day 1]
- Enamel Remineralization Assessed by Raman Spectroscopy [Time frame: day 7]
- Ion Release from Modified Aligner Resin [Time frame: day 7]
Secondary outcome measures (5)
- Tensile Properties of Modified 3D-Printed Aligner Resin [Time frame: After specimen fabrication and post-curing (Day 1)]
- Flexural Properties of Modified 3D-Printed Aligner Resin [Time frame: (Day 1)]
- Shape Memory [Time frame: day 1]
- Water Sorption and Solubility [Time frame: day 1 to day 7]
- Optical Properties: Translucency [Time frame: day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Iraq · 1 center
- College of Dentistry, University of Baghdad — Baghdad
Identifiers
NCT: NCT07603427 · 1161426