Status:
RECRUITING
Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
American Association of Orthodontists Foundation
Conditions:
Obesity & Overweight
Orthodontic Treatment
Eligibility:
All Genders
12-18 years
Brief Summary
The goal of this prospective observational study is to assess the influence of increased body mass index (BMI) on various oral health and orthodontic-related parameters in adolescents undergoing ortho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07217756
Start Date
April 22 2022
End Date
November 1 2026
Last Update
October 20 2025
Active Locations (1)
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1
Eastman Institute for Oral Health, University of Rochester
Rochester, New York, United States, 14620