Antibiofilm Activity of Chitosan Nanoparticles Incorporated Into Clear Aligners

NCT06823310 | Active Not Recruiting

• 1 other identifier: 1015425
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Clear Aligners; Chitosan; Nanoparticles; 3D printing; Anti-biofilm

Outcome Measures

Primary Outcomes (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.

  2 weeks

Secondary Outcomes (1)

• Self-reported questionnaire about satisfaction of wearing clear aligner (control and experimental)

  2 weeks

Study Arms (2)

Control

OTHER

control directly printed orthodontic clear aligners without chitosan nanoparticles

Device: Control (Standard treatment)

chitosan

EXPERIMENTAL

Directly printed orthodontic clear aligners with chitosan nanoparticles

Device: Chitosan

Interventions

Control (Standard treatment) DEVICE

Directly printed orthodontic clear aligner without any additions

Control

Chitosan DEVICE

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

chitosan

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• any criteria not mentioned above

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Al-Resafa, 1011, Iraq

Location

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 12, 2025
• Study Start: January 25, 2025
• Primary Completion: April 25, 2025
• Study Completion: May 25, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)