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Could a new mouthwash help kids with braces fight plaque and bad breath?

NCT ID NCT07710144

Disease control Sponsor: Plovdiv Medical University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study tests whether a new, chlorhexidine-free mouthwash can reduce plaque buildup, gum inflammation, and bad breath in children aged 12 to 17 who wear fixed metal braces. Participants rinse twice daily for 21 days alongside their usual brushing and flossing. The trial compares the test mouthwash against a standard chlorhexidine rinse and a placebo to see which works best and is most tolerable.

What this could mean

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

Active substance
a prototype chlorhexidine-free pediatric mouthwash
What this could lead to
If effective, this mouthwash could offer a gentler, alcohol-free option to help children with braces maintain oral hygiene and prevent gum disease.
What could go wrong
This is a small, short-term study (90 children, 21 days), so results may not apply to all kids or predict long-term benefits. The test mouthwash may not outperform standard chlorhexidine rinses.

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 90 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 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 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Participants aged 12 to 17 years. 2. Presence of fixed metal orthodontic appliances placed at least 6 months before enrollment. 3. Generalized plaque-induced gingivitis. 4. Full Mouth Bleeding Score greater than 30%. 5. Gingival Index greater than 0.95 according to Loe and Silness. 6. Written informed consent obtained from a parent or legal guardian. 7. Participant willingness to comply with the study protocol. Exclusion Criteria: 1. Refusal to participate or withdrawal of informed consent. 2. Non-compliance with the intervention regimen or inability to attend follow-up visits. 3. Development of an adverse reaction or condition requiring discontinuation. 4. Antibiotic or antimicrobial therapy during follow-up if it may affect the study outcomes. 5. Presence of concomitant systemic diseases. 6. Current systemic medication intake that could influence oral health or inflammatory status. 7. Use of systemic or local antimicrobial agents during the previous 3 months, including mouthwashes, gels, chewing gums or other local oral agents. 8. Known allergy or hypersensitivity to any component of the tested mouthwash formulations. 9. Use of removable orthodontic appliances only. Inability or unwillingness to follow the study instructions.

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Conditions

The condition(s) this trial relates to.

gingivitis Halitosis

As listed by the trial registrant

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

Dental plaque accumulation Halitosis Plaque induced gingivitis

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

  • Department of Paediatric dentistry, Faculty of Dental Medicine, Medical University of Plovdiv

    Plovdiv, 4000, Bulgaria

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