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Antibiofilm Activity of Chitosan Nanoparticles Incorporated Into Clear Aligners

NCT06823310 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-12

No results posted yet for this study

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 .

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.

Conditions

  • Malocclusion, Angle Class I

Interventions

DEVICE

Control (Standard treatment)

Directly printed orthodontic clear aligner without any additions

DEVICE

Chitosan

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

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2025-04-25
Completion
2025-05-25

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06823310 on ClinicalTrials.gov