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Malocclusion, Angle Class INCT06823310

Antibiofilm Activity of Chitosan Nanoparticles Incorporated Into Clear Aligners

A study testing Chitosan in people with Malocclusion, Angle Class I, run by University of Baghdad at 1 site in Iraq.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The use of orthodontic appliances and equipment has dramatically increased over the past few decades, mainly due to improvements in materials and manufacturing processes that have paved the way for improved treatments . Read more about this study

Who is it for?
Ages 18 to 28 years
Conditions the study is for
Malocclusion, Angle Class I
What is being tested?
Chitosan
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteIraq
Study dates
25 Jan 2025to 25 May 2025
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 18 to 28 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Subjects falling in the age group of 18-28 years with mild malocclusion
  • Full permanent dentition except for third molars
  • Plaque score and Bleeding on probing should be less than 10% (O'Leary et al., 1972)
  • No previous history of para-functional habits

Who cannot join

  • any criteria not mentioned above
  • -

Trial locations and contacts

1 site in 1 country.

Iraq1 site
  • College of Dentistry, University of Baghdad

    Baghdad, Al-Resafa, 1011

Other trials in Iraq

About this study

Official title: Antibiofilm Activity of Directly Printed Orthodontic Clear Aligners With Incorporated Chitosan Nanoparticles (A Randomized Clinical Trial)

The use of orthodontic appliances and equipment has dramatically increased over the past few decades, mainly due to improvements in materials and manufacturing processes that have paved the way for improved treatments .

The preference for aligner treatment and the increase in its prevalence can be attributed to patient demand for "invisible" treatments and the limitations of conventional fixed orthodontics . Direct 3D printing offers the possibility of creating highly precise clear aligners with soft edges, digitally designed and identically reproduced for an entire set of treatment aligners. These provide a better fit, higher efficacy, and reproducibility .

Clear aligner treatment demonstrated promising results in terms of controlling plaque index, gingival health, and the prevalence of white spot lesions. Nevertheless, grooves, ridges, microcracks, and abrasions on the aligner surface provide a prime environment for bacterial adherence and the development of plaque biofilms. Adding chitosan, a minimally toxic agent with antibacterial properties and the ability to reduce enamel demineralization, to 3D-printed aligner resin materials may decrease the incidence of WSLs . Currently, there is limited research on including nanoparticles in aligners' material for microbe inhibition and, to the best of our knowledge, none of the research has assessed and compared the effect of adding chitosan to an aligner's resin.

Read the detailed description

The use of orthodontic appliances and equipment has dramatically increased over the past few decades, mainly due to improvements in materials and manufacturing processes that have paved the way for improved treatments .

The preference for aligner treatment and the increase in its prevalence can be attributed to patient demand for "invisible" treatments and the limitations of conventional fixed orthodontics. Direct 3D printing offers the possibility of creating highly precise clear aligners with soft edges, digitally designed and identically reproduced for an entire set of treatment aligners. These provide a better fit, higher efficacy, and reproducibility.

Clear aligner treatment demonstrated promising results in terms of controlling plaque index, gingival health, and the prevalence of white spot lesions. Nevertheless, grooves, ridges, microcracks, and abrasions on the aligner surface provide a prime environment for bacterial adherence and the development of plaque biofilms. A combination of mechanical and chemical methods seem to be a successful approach for removing plaque biofilm from aligners whilst preventing pigment adsorption.

Orthodontic appliances change the ecological environment of the oral cavity, resulting in a significant increase in the number of cariogenic bacteria such as Streptococcus mutans (S. mutans). The imbalance in oral homeostasis can lead to enamel demineralization, periodontitis and other bacteria-related adverse effects of orthodontic treatment. According to evidence-based clinical assessments, once enamel demineralization is formed it is difficult to be fully reversed using currently available remineralizing agents. Thus, several antibacterial strategies have been used clinically to prevent enamel demineralization, including antibacterial mouthwashes and toothpastes. However, these conventional interventions are largely dependent on perfect compliance from the patients, which most of the times does not occur.

Chitosan nanoparticles have a wide range of applications and have long been employed with or without other substances and techniques to increase their functionality .

Adding chitosan, a minimally toxic agent with antibacterial properties and the ability to reduce enamel demineralization, to 3D-printed aligner resin materials may decrease the incidence of WSLs . Currently, there is limited research on including nanoparticles in aligners' material for microbe inhibition and, to the best of our knowledge, none of the research has assessed and compared the effect of adding chitosan to an aligner's resin . A recent study carried out by Taher and Rasheed in 2023 added chitosan nanoparticles at different concentrations (2%, 3%, and 5% w/w) to directly 3D-printed clear aligner resin and assessed its anti-biofilm activity (on Streptococcus mutans bacteria categorized as one of the most virulent bacteria to cause enamel lesions), degree of conversion, accuracy, deflection force, and tensile strength. Additionally, cytotoxicity has been assessed using tissue cultures of mice fibroblasts and embryonic cells of chitosan (2%, 3%, and 5% w/w). The results of this essay showed that all used concentrations were non cytotoxic to living cells. It was found that there was a notable reduction in bacterial colonies when the resin was incorporated with 3% and 5% chitosan nanoparticles. No significant changes in the cytotoxicity or accuracy were detected and it was concluded that integrating biocompatible chitosan nanoparticles into the resin can add an anti-biofilm element to an aligner without compromising the material's particular biological, mechanical, and physical qualities at specific concentrations.

As the previous study was carried out in vitro, this study aims at assessing the effect of in vivo aging on the anti-biofilm and anti-microbial activity of chitosan incorporated into directly printed clear aligner resin.

Being tested
Control (Standard treatment), Chitosan
Keywords
Clear Aligners, Chitosan, Nanoparticles, 3D printing, Anti-biofilm
Medical subject headings
Malocclusion, Angle Class I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control (Standard treatment)Device

    Directly printed orthodontic clear aligner without any additions

  • ChitosanDevice

    Adding chitosan nanoparticles to directly printed orthodontic clear aligners in vivo to enhance anti- microbial activity against streptococcus mutans.

Study groups in NCT06823310
Study groupRoleWhat they receive
ControlOthercontrol directly printed orthodontic clear aligners without chitosan nanoparticles
Receives: Device: Control (Standard treatment)
chitosanExperimentalDirectly printed orthodontic clear aligners with chitosan nanoparticles
Receives: Device: Chitosan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antimicrobial properties of chitosan nanoparticles incorporated into directly 3D printed clear orthodontic aligner will be assessed by using antibiofilm assay

    The main outcome of this study is yo determine the antimicrobial effect of chitosan nanoparticles directly added to 3D printed clear aligners against Streptococcus mutans. This will be conducted by using antibiofilm activity test at baseline, 1 week, and 2 weeks following wearing conventional and chitosan-incorporated clear aligners. From each device retrieved from the patients at these timepoints, a 5mm diameter disc will be cut from the labial aspect of the devices. These discs will be cultured overnight in a broth containing equal number of S. mutans bacteria. After 24 h, the number of vital bacteria and the biomass will be measured to determine the antibiofilm activity of chitosan-incorporated devices vs control.

    Measured: 2 weeks

Secondary outcomes (1)
  1. Self-reported questionnaire about satisfaction of wearing clear aligner (control and experimental)

    To asses perceived patients outcome i.e., degree of satisfaction by using a questionnaire designed for this purpose about wearing both devices (control and experimental). The questionnaire consists of two sections. The first section is dedicated for collecting demographic and lifestyle variables. The second section is designed to assess the degree of satisfaction by answering close-end questions. Each positive response will be scored as "1" while negative response will be scored "0". The sum of these responses will represent the overall satisfaction for each patient.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2025
  2. Study start25 Jan 2025
  3. Primary completion25 Apr 2025 (estimated)
  4. Study completion25 May 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06823310
Sponsor's protocol ID
1015425
Status last verified
Feb 2025
First submitted
2 Feb 2025
Last updated
12 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alhuwaizi MA, Saloom HF. Antibiofilm activity of chitosan nanoparticles incorporated into three-dimensional printed clear aligners on Streptococcus mutans after in vivo aging: A randomized clinical trial. J World Fed Orthod. 2026 Feb;15(1):38-45. doi: 10.1016/j.ejwf.2025.09.003. Epub 2025 Oct 9.

    PubMed 41073253

Questions about this trial

What is this clinical trial studying?

A study testing Chitosan in people with Malocclusion, Angle Class I, 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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2025. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antimicrobial properties of chitosan nanoparticles incorporated into directly 3D printed clear orthodontic aligner will be assessed by using antibiofilm assay (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06823310, which also lists 1 linked publication.

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 12 Feb 2025.

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