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Could a tooth cleanser coating make braces screws more stable?

NCT ID NCT05639907

Symptom relief Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether coating orthodontic miniscrews with an antimicrobial liquid called K21 can reduce gum inflammation and keep the screws stable. Thirty people needing at least two miniscrews will have one screw coated with K21 and the other with a placebo (ethanol). The researchers will check for redness, swelling, and screw movement over 8 weeks.

What this could mean

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

Active substance
K21 cavity cleanser (antimicrobial quaternary ammonium compound)
What this could lead to
If it works, this could reduce gum inflammation and improve the success rate of orthodontic miniscrews, making braces treatment more comfortable and reliable.
What could go wrong
This is a small early-stage trial with only 30 people, so results may not apply to everyone. The K21 coating might not reduce inflammation or improve stability more than the control.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jun 2028

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

12 years and older

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: 1. Good general health, with no significant medical findings 2. Requiring at least two miniscrews in their treatment plans (i.e., most participants will have two miniscrews, but some may receive four or six as indicated by their individual treatment plan) 3. Miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage). Exclusion Criteria: 1. Recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews 2. Less than 12 years of age 3. Heavy tobacco use (\>10 cigarettes/day) 4. Peri-implant tissues must be observable at follow-up appointments 5. Being unable or unwilling to consent to the study

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Conditions

The condition(s) this trial relates to.

Inflammation

As listed by the trial registrant

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

Inflammation caused by the placement of A temporary anchorage device

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Colorado School of Dental Medicine

    RECRUITING

    Aurora, Colorado, 80045, United States