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Could a Tooth-Friendly coating on clear aligners stop white spots before they start?

NCT ID NCT07715552

Disease control Sponsor: Jordan University of Science and Technology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This trial tests whether coating clear orthodontic aligners with nano chitosan—a natural antimicrobial—can reduce white spot lesions (early enamel damage) that sometimes develop during aligner therapy. About 53 people with mild to moderate misalignment will wear either coated or uncoated aligners. Researchers will measure changes in enamel mineral loss using a special fluorescence imaging system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a nano chitosan coating applied to clear orthodontic aligners
What this could lead to
If effective, this coating could help prevent enamel damage during clear aligner therapy, reducing the need for additional dental treatments.
What could go wrong
This is a small, early-stage trial with only 53 participants, so results may not apply broadly. The coating's long-term durability and safety are not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

53 people

The number who actually took part.

Started

Oct 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 30 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

dental fluorosis prevention target enamel caries prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

White spot lesions

Contacts and locations

Locations

  • Postgraduate Orthodontic Clinics

    Irbid, 22110, Jordan

More trials for these conditions

Other studies related to the condition(s) this trial covers.