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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Safaa Saud Abed
- Telefonnummer: 009647712375540
- E-post: safaasaud83@gmail.com
Studera Kontakt Backup
- Namn: Ali I Ibrahim
- E-post: ali.ibrahim@kcl.ac.uk
Studieorter
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Baghdad Governorate
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Baghdad, Baghdad Governorate, Irak, 1417
- College of Dentistry, University of Baghdad
-
Kontakt:
- Ali I Ibrahim, professor of orthodontics
- Telefonnummer: 00964 7705814633
- E-post: ali.ibrahim@kcl.ac.uk
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Experimentell: 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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Experimentell: 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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Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Antimicrobial Activity of Modified 3D-Printed Aligner Resin
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Tensile Properties of Modified 3D-Printed Aligner Resin
Tidsram: 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
Tidsram: (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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Ali I Ibrahim, Prof. Dr, University of Baghdad
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 1161426
Plan för individuella deltagardata (IPD)
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