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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Safaa Saud Abed
- Telefonnummer: 009647712375540
- E-post: safaasaud83@gmail.com
Studer Kontakt Backup
- Navn: Ali I Ibrahim
- E-post: ali.ibrahim@kcl.ac.uk
Studiesteder
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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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Ta kontakt med:
- Ali I Ibrahim, professor of orthodontics
- Telefonnummer: 00964 7705814633
- E-post: ali.ibrahim@kcl.ac.uk
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Antimicrobial Activity of Modified 3D-Printed Aligner Resin
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Tensile Properties of Modified 3D-Printed Aligner Resin
Tidsramme: 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
Tidsramme: (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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Ali I Ibrahim, Prof. Dr, University of Baghdad
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 1161426
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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