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.
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.
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.
- Conditions
- Malocclusion, Angle Class I
- 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 group | Role | What they receive |
|---|---|---|
| Control | Other | control directly printed orthodontic clear aligners without chitosan nanoparticles Receives: Device: Control (Standard treatment) |
| chitosan | Experimental | Directly 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.
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)
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.
- First posted12 Feb 2025
- Study start25 Jan 2025
- Primary completion25 Apr 2025 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Angle Class IStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malak Akram Alhuwaizi, University of Baghdad
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiofilm Activity of Directly Printed Orthodontic Clear Aligners With Incorporated Chitosan Nanoparticles (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06823310
- Acronym / sponsor ID
- 1015425
- Conditions
- Malocclusion, Angle Class I
- Keywords
- Clear Aligners, Chitosan, Nanoparticles, 3D printing, Anti-biofilm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 12 Feb 2025 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Device: Control (Standard treatment)control directly printed orthodontic clear aligners without chitosan nanoparticles |
| chitosan | Experimental | Device: ChitosanDirectly printed orthodontic clear aligners with chitosan nanoparticles |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- any criteria not mentioned above
- -
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 |
|---|---|---|
| Control (Standard treatment)Directly printed orthodontic clear aligner without any additions | Device | Control |
| ChitosanAdding chitosan nanoparticles to directly printed orthodontic clear aligners in vivo to enhance anti- microbial activity against streptococcus mutans. | Device | chitosan |
Primary outcome
Antimicrobial properties of chitosan nanoparticles incorporated into directly 3D printed clear orthodontic aligner will be assessed by using antibiofilm assay
Time frame: 2 weeks
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.
1 secondary outcome
Self-reported questionnaire about satisfaction of wearing clear aligner (control and experimental)
Time frame: 2 weeks
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 12 Feb 2025.
- Derived from this study: PubMed 41073253Alhuwaizi 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.
- Individual participant dataSharing planned: No
Related trials for Malocclusion, Angle Class I
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Effect of Early Versus Late Premolar Extraction on Orthodontic Tooth Movement
Malocclusion Class II, Malocclusion, Angle Class I
Not yet recruiting
3D Printed Occlusal Splints for Intraoperative Use
Malocclusion, Angle Class I, Malocclusion, Angle Class II
Not yet recruiting
Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
Angle Class I Maloclussion, Dental Crowding
Recruiting
Clinical Performance of Direct-Printed Versus Thermoformed Aligners
Angle Class I Malocclusion, Dental Crowding
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.