How higher body mass index affects teens' braces, gums, and tooth health.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study enrolling adolescents aged 12–17 who are starting comprehensive fixed orthodontic treatment with metal braces on both arches. Participants will be grouped by BMI (normal 18.5–24.99 vs increased ≥25.0 kg/m2) and followed for at least six months during treatment. Investigators will measure gum inflammation, tooth decalcifications/discolorations, alignment of the lower incisors, and inflammatory and microbiological markers in saliva and gingival crevicular fluid at baseline and follow-up visits. No experimental interventions are given; the study aims to correlate BMI status with clinical oral and laboratory outcomes during orthodontic therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Eastman Institute for Oral Health, University of Rochester
  Rochester, New York, United States Recruiting

Study contacts

• Principal investigator: Dimitrios Michelogiannakis, DDS, MS — Eastman Institute for Oral Health, University of Rochester
• Study coordinator: Dimitrios Michelogiannakis, DDS, MS
• Email: Dimitrios_Michelogiannakis@URMC.Rochester.edu
• Phone: 585-275-5012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.