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Orthodontic treatment may trigger cellular stress responses in children

NCT ID NCT07695584

Knowledge-focused Sponsor: IRCCS Ospedale San Raffaele Source: ClinicalTrials.gov ↗

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 10, 2026 · Last updated Jul 10, 2026

Summary

This study investigates whether rapid maxillary expansion—a common orthodontic procedure to widen the upper jaw—causes changes in oxidative stress and antioxidant levels in children aged 10 to 13. Researchers measured specific biomarkers in gum fluid from 14 children undergoing the procedure and compared them to 14 untreated children. The goal is to understand the local biological response to the mechanical forces of expansion.

What this could mean

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

What this could lead to
If successful, this research could help orthodontists understand the biological effects of rapid maxillary expansion and potentially improve treatment protocols.
What could go wrong
This is a small pilot study with only 28 participants, so results may not apply to all patients. It measures biomarkers, not clinical outcomes, so direct treatment benefits are uncertain.

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

28 people

The number who actually took part.

Started

Mar 2011

Finished

Jun 2012

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

10 to 13 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: * Age between 10 and 13 years. * Good general health. * Fully erupted maxillary premolars. * Healthy periodontal status, with probing depth of 3 mm or less. * For the intervention group, a clinical indication for rapid maxillary expansion. * For the control group, no orthodontic treatment planned during the observation period. * Ability to comply with the clinical examination and gingival crevicular fluid sampling schedule. * Written informed consent from the participant's parent or legal guardian and assent from the participant, where applicable. Exclusion Criteria: * Systemic disease. * Current medication use that could influence periodontal, inflammatory, or oxidative status. * Active periodontal disease. * Probing depth greater than 3 mm. * Inability to comply with the oral hygiene protocol or study visits.

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As listed by the trial registrant

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

Oxidative stress Transverse maxillary deficiency

Contacts and locations

Locations

  • Izmir Democracy University

    Izmir, 35140, Turkey (Türkiye)

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