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Teens with higher BMI may face more gum trouble during braces treatment

NCT ID NCT07217756

Knowledge-focused Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 52 teens (ages 12–17) getting braces to see if having a higher body weight leads to more gum inflammation, white spots on teeth, and higher levels of certain mouth bacteria. Researchers will compare overweight and normal-weight participants by checking saliva, gum fluid, and dental photos at the start and after 6 months. No treatment is given—this is an observation-only study to understand risk factors.

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.

Participants

About 52 people

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

Started

Apr 2022

Expected to finish

Nov 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.

Who is studied

Adolescent patients undergoing fixed orthodontic therapy at the Eastman Institute for Oral Health, University of Rochester, NY.

Ages

12 to 18 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: * adolescents (12-17 years old); * patients scheduled to undergo comprehensive fixed orthodontic therapy (OT) (for at least 6 months with metal braces/wires) on both dental arches; * patients with increased BMI (≥25.0 Kg/m2) (test-Group); * patients with normal BMI \[18.5-24.99 (Kg/m2)\] (control-Group); * patients with all 6 mandibular anterior teeth present and mild-to-moderate mandibular crowding (\<7.5 mm); * patients and parents/guardians willing to provide signed assent/permission. Exclusion Criteria: * self-reported habitual tobacco product users; * patients with self-reported medical diseases such as hepatic diseases, blood disorders, cardiovascular diseases, HIV, diabetes mellitus, and viral infections; * patients with craniofacial syndromes and/or cleft lip and palate; * pregnant and/or lactating females (by self/parent report); * edentulous individuals; * patients with active or a history of periodontitis; * patients having undergone surgical and/or non-surgical periodontal therapy within the past 6 months; * patients with physical and/or mental/cognitive disabilities who are decisionally-impaired and not able to consent/assent for themselves; * patients who reported use of medications such as antibiotics, steroids (inhalers and/or pills), non-steroidal anti-inflammatory drugs, and antimicrobial mouth-rinses within the past 3 months or those who require prophylactic antibiotics prior to dental procedures; * patients undergoing cancer therapy; * underweight patients (BMI less than 18.5 Kg/m2); * patients with oral mucosal lesions such as median rhomboid glossitis and lichen planus; * patients with clinically visible carious teeth.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

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

Obesity / overweight Orthodontic treatment

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

  • Eastman Institute for Oral Health, University of Rochester

    RECRUITING

    Rochester, New York, 14620, United States

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