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

NCT07715552 | Active Not Recruiting DMC

• 1 other identifier: JUST20250008
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesions

Keywords

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

Outcome Measures

Primary Outcomes (2)

• White spot lesion area

  It measures the area of enamel demineralization in pixels (Using the QLF system)

  3 months

• Mean of fluorescence loss (Delta F) in percent

  It 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

  3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Chitosan nanoparticle coating of the clear orthodontic aligners that will be used by the participants

Other: chitosan nanoparticles

Control

PLACEBO COMPARATOR

The clear orthodontic aligners that will be used by the participants are not coated with anything.

Other: No Treatment Added

Interventions

chitosan nanoparticles OTHER

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

Intervention

No Treatment Added OTHER

No coating of the orthodontic aligners

Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead
• Deanship of Scientific Research/Jordan University of Science and Technology: collaborator

Study Sites (1)

Postgraduate Orthodontic Clinics

Irbid, 22110, Jordan

Location

Study Officials

• Susan Al-Khateeb

  Jordan University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 20, 2026
• Study Start: October 12, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): October 29, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)