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The Effect of Nano Chitosan Surface Coating on White Spot Lesions Development in Clear Aligner Therapy Patients

The Effect of Nano Chitosan Carboxymethyle Methyle Cellulose Surface Coating on White Spot Lesions Development in Patients With Clear Aligner Therapy: Prospective Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07715552
Enrollment
53
Registered
2026-07-20
Start date
2025-10-12
Completion date
2026-10-29
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesions

Keywords

Chitosan nanoparticles, White spot lesions, Demineralization, QLF, Chitosan nanoparticles, White spot lesions, Enamel Demineralization, Quantitative Light-Induced Fluorescence (QLF)

Brief summary

In this study, it was intended to investigate the effect of nano Chitosan (antimicrobial agent) coating on clear aligner orthodontic appliance if it reduces the incidence of white spot lesions (demineralization) of enamel surfaces.

Detailed description

White spot lesions (WSLs) are a common complication of orthodontic treatment and represent the earliest stage of enamel demineralization. Although clear aligner therapy is generally associated with a lower risk of WSL development than fixed appliances, enamel demineralization may still occur during treatment. Chitosan nanoparticles possess antimicrobial properties and have shown potential for preventive dental applications. This study investigated the effectiveness of chitosan nanoparticle-coated clear aligners in limiting enamel demineralization during orthodontic treatment. A prospective two-arm parallel-group randomized controlled clinical trial was conducted on 53 patients (18-29 years) undergoing clear aligner therapy. Participants were randomly allocated into two groups: conventional clear aligners (control) and chitosan nanoparticle-coated clear aligners (experimental). Three participants were lost to follow-up, and 50 patients (25 per group) were included in the final analysis. Chitosan nanoparticles were prepared using ionic gelation and applied to aligner surfaces following atmospheric plasma treatment. Surface characterization was performed using profilometry, scanning electron microscopy (SEM), and energy-dispersive X-ray analysis (EDAX). White spot lesions were assessed at baseline and after six months using quantitative light-induced fluorescence (QLF)

Interventions

Clear orthodontic aligners will be coated with nanoparticle sized Chitosan to investigate its anti-microbial effect on development of white spot lesions underneath the aligners

No coating of the orthodontic aligners

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER
Deanship of Scientific Research/Jordan University of Science and Technology
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients presenting with mild to moderate malocclusion (sagittal, vertical, transverse discrepancies, or crowding) that could be treated using clear aligners within a maximum treatment period of one year and without the need for extraction therapy. * Medically healthy patients with no systemic diseases or medical conditions that could affect enamel integrity, salivary flow, oral hygiene status, or periodontal health. * Patients with no history of previous orthodontic treatment, dental trauma, or parafunctional habits such as bruxism. * Patients with good oral hygiene and absence of active periodontal disease, including gingivitis or periodontitis. * Patients willing to comply with the prescribed clear aligner wear protocol for a minimum of 22 hours per day. * Patients who agreed to participate in the study and signed the informed consent form.

Exclusion criteria

* Previous orthodontic treatment that could influence baseline enamel condition or white spot lesion assessment. * Presence of active carious lesions, cavitated lesions, severe enamel hypoplasia, or developmental enamel defects. * Extensive restorations on anterior teeth that could interfere with Quantitative Light-Induced Fluorescence (QLF) imaging and analysis. * Systemic diseases or medical conditions affecting salivary flow, enamel integrity, oral hygiene, or periodontal health. * Use of medications known to affect salivary secretion, enamel mineralization, or oral microbial balance. * Poor oral hygiene or presence of active periodontal disease, including gingivitis or periodontitis.

Design outcomes

Primary

MeasureTime frameDescription
White spot lesion area3 monthsIt measures the area of enamel demineralization in pixels (Using the QLF system)
Mean of fluorescence loss (Delta F) in percent3 monthsIt measures the percentage of fluorescence loss in the white spot lesion compared to that of sound enamel reflecting the amount of mineral loss using the QLF system

Countries

Jordan

Contacts

STUDY_DIRECTORSusan Al-Khateeb

Jordan University of Science and Technology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026