Orthodontic Aligner Material3D-BIOALIGNNCT07603427
Development of Biofunctional 3D-Printed Orthodontic Aligners With Antimicrobial and Remineralizing Properties
A study testing Modified 3D-Printed Orthodontic Aligner Resin in people with Orthodontic Aligner Material and Enamel Demineralization, run by University of Baghdad at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthodontic Aligner Material, Enamel Demineralization, Dental Biofilm Formation
- What is being tested?
- Modified 3D-Printed Orthodontic Aligner Resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jun 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali I Ibrahim contact
Iraq1 site
College of Dentistry, University of Baghdad
Baghdad, Baghdad Governorate, 1417
Ali I Ibrahim, professor of orthodontics, 00964 7705814633, ali.ibrahim@kcl.ac.uk
About this study
Official title: 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.
Read more
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
- Conditions
- Orthodontic Aligner Material, Enamel Demineralization, Dental Biofilm Formation, Clear Aligner Material Properties
- Being tested
- Modified 3D-Printed Orthodontic Aligner Resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified 3D-Printed Orthodontic Aligner ResinOther
Directly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | Directly 3D-printed orthodontic aligner resin Receives: Other: Modified 3D-Printed Orthodontic Aligner Resin |
| DMAHDM group | Experimental | Directly 3D-printed orthodontic aligner resin with incorporation of dimethylaminohexadecyl methacrylate (DMAHDM) Receives: Other: Modified 3D-Printed Orthodontic Aligner Resin |
| ACP group | Experimental | Directly 3D-printed orthodontic aligner resin with incorporation of Amorphous calcium phosphate (ACP) Receives: Other: Modified 3D-Printed Orthodontic Aligner Resin |
| DMAHDM + ACP group | Experimental | Directly 3D-printed orthodontic aligner resin with incorporation both DMAHDM and ACP Receives: Other: Modified 3D-Printed Orthodontic Aligner Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial Activity of Modified 3D-Printed Aligner Resin
Evaluation of antibacterial effectiveness by quantifying Streptococcus mutans biofilm using colony-forming unit (CFU) counts (CFU/mL
Measured: day 1
Enamel Remineralization Assessed by Raman Spectroscopy
Assessment of mineral content changes in enamel adjacent to aligner material using Raman spectroscopy (e.g., phosphate ν1 peak intensity at ~960 cm-¹).
Measured: day 7
Ion Release from Modified Aligner Resin
Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)
Measured: day 7
Secondary outcomes (5)
Tensile Properties of Modified 3D-Printed Aligner Resin
Assessment of tensile strength and elastic modulus of unmodified and modified aligner resins according to ISO 527-2.Unit of Measure: MPa.
Measured: After specimen fabrication and post-curing (Day 1)
Flexural Properties of Modified 3D-Printed Aligner Resin
Evaluation of flexural strength and flexural modulus using a three-point bending test.Unit of Measure: MPa
Measured: (Day 1)
Shape Memory
Assessment of shape recovery rate (%) Unit of Measure: % (recovery)
Measured: day 1
Water Sorption and Solubility
Measurement of water sorption and solubility according to ISO 20795-1. Unit of Measure: µg/mm³
Measured: day 1 to day 7
Optical Properties: Translucency
Evaluation of translucency parameter (TP) using spectrophotometric analysis. Unit of Measure: Translucency Parameter (TP)
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Aligner MaterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel experimental groups comparing unmodified and modified 3D-printed orthodontic aligner materials
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Saud Abed, University of Baghdad
- Investigators
- Ali I Ibrahim, Prof. Dr, Study chair, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603427
- Sponsor's protocol ID
- 1161426
- Acronym
- 3D-BIOALIGN
- Status last verified
- May 2026
- First submitted
- 24 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participants confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biofunctional 3D Printed Orthodontic Aligners Enriched With Remineralizing and Anti-microbial Agents
- ClinicalTrials.gov ID
- NCT07603427
- Acronym / sponsor ID
- 3D-BIOALIGN / 1161426
- Conditions
- Orthodontic Aligner Material, Enamel Demineralization, Dental Biofilm Formation, Clear Aligner Material Properties
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Parallel experimental groups comparing unmodified and modified 3D-printed orthodontic aligner materials
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: Modified 3D-Printed Orthodontic Aligner ResinDirectly 3D-printed orthodontic aligner resin |
| DMAHDM group | Experimental | Other: Modified 3D-Printed Orthodontic Aligner ResinDirectly 3D-printed orthodontic aligner resin with incorporation of dimethylaminohexadecyl methacrylate (DMAHDM) |
| ACP group | Experimental | Other: Modified 3D-Printed Orthodontic Aligner ResinDirectly 3D-printed orthodontic aligner resin with incorporation of Amorphous calcium phosphate (ACP) |
| DMAHDM + ACP group | Experimental | Other: Modified 3D-Printed Orthodontic Aligner ResinDirectly 3D-printed orthodontic aligner resin with incorporation both DMAHDM and ACP |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified 3D-Printed Orthodontic Aligner ResinDirectly 3D-printed orthodontic aligner resin with or without incorporation of antimicrobial (DMAHDM) and remineralizing (ACP) agents. | Other | ACP group, DMAHDM + ACP group, DMAHDM group, control group |
Primary outcome
Antimicrobial Activity of Modified 3D-Printed Aligner Resin
Time frame: 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
Time frame: 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
Time frame: day 7
Quantification of calcium (Ca²⁺) and phosphate (PO₄³-) ion release using inductively coupled plasma (ICP) analysis (ppm)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. participants confidentiality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali I Ibrahim contact
Ali I Ibrahim, Prof. Dr study chair
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified 3D-Printed Orthodontic Aligner Resin in people with Orthodontic Aligner Material and Enamel Demineralization, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Safaa Saud Abed (009647712375540, safaasaud83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial Activity of Modified 3D-Printed Aligner Resin (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.