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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Safaa Saud Abed
- Telefoonnummer: 009647712375540
- E-mail: safaasaud83@gmail.com
Studie Contact Back-up
- Naam: Ali I Ibrahim
- E-mail: ali.ibrahim@kcl.ac.uk
Studie Locaties
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Irak, 1417
- College of Dentistry, University of Baghdad
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Contact:
- Ali I Ibrahim, professor of orthodontics
- Telefoonnummer: 00964 7705814633
- E-mail: ali.ibrahim@kcl.ac.uk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: control group
Directly 3D-printed orthodontic aligner resin
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Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
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Experimenteel: DMAHDM group
Directly 3D-printed orthodontic aligner resin with incorporation of dimethylaminohexadecyl methacrylate (DMAHDM)
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Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
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Experimenteel: ACP group
Directly 3D-printed orthodontic aligner resin with incorporation of Amorphous calcium phosphate (ACP)
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Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
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Experimenteel: DMAHDM + ACP group
Directly 3D-printed orthodontic aligner resin with incorporation both DMAHDM and ACP
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Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Antimicrobial Activity of Modified 3D-Printed Aligner Resin
Tijdsspanne: day 1
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Evaluation of antibacterial effectiveness by quantifying Streptococcus mutans biofilm using colony-forming unit (CFU) counts (CFU/mL
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day 1
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Enamel Remineralization Assessed by Raman Spectroscopy
Tijdsspanne: day 7
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Assessment of mineral content changes in enamel adjacent to aligner material using Raman spectroscopy (e.g., phosphate ν1 peak intensity at ~960 cm-¹).
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day 7
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Ion Release from Modified Aligner Resin
Tijdsspanne: day 7
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Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)
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day 7
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Tensile Properties of Modified 3D-Printed Aligner Resin
Tijdsspanne: After specimen fabrication and post-curing (Day 1)
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Assessment of tensile strength and elastic modulus of unmodified and modified aligner resins according to ISO 527-2.Unit of Measure: MPa.
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After specimen fabrication and post-curing (Day 1)
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Flexural Properties of Modified 3D-Printed Aligner Resin
Tijdsspanne: (Day 1)
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Evaluation of flexural strength and flexural modulus using a three-point bending test.Unit of Measure: MPa
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(Day 1)
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Shape Memory
Tijdsspanne: day 1
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Assessment of shape recovery rate (%) Unit of Measure: % (recovery)
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day 1
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Water Sorption and Solubility
Tijdsspanne: day 1 to day 7
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Measurement of water sorption and solubility according to ISO 20795-1.
Unit of Measure: µg/mm³
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day 1 to day 7
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Optical Properties: Translucency
Tijdsspanne: day 1
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Evaluation of translucency parameter (TP) using spectrophotometric analysis.
Unit of Measure: Translucency Parameter (TP)
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day 1
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie stoel: Ali I Ibrahim, Prof. Dr, University of Baghdad
Studie record data
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Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 1161426
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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