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ACTIVE NOT RECRUITING
NCT06823310
NA

Antibiofilm Activity of Chitosan Nanoparticles Incorporated Into Clear Aligners

Sponsor: University of Baghdad

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 28 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-01-25

Completion Date

2025-05-25

Last Updated

2025-02-12

Healthy Volunteers

No

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.

Locations (1)

College of Dentistry, University of Baghdad

Baghdad, Al-Resafa, Iraq