Actively Recruiting
Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study
Led by University of Rochester · Updated on 2025-10-20
52
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
A
American Association of Orthodontists Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 orthodontic therapy (OT) with braces. These parameters include gum inflammation, tooth decalcifications/discolorations, tooth alignment of lower incisors, and various inflammatory and microbiological parameters in the collected saliva and gum fluid of the patients. The primary purpose is to assess if an increased BMI is a risk factor for oral inflammation in adolescents undergoing OT. The main questions it aims to answer are: 1. Do patients with an increased BMI undergoing OT demonstrate increased microbial counts in the saliva compared to patients with normal BMI? 2. Do patients with increased BMI undergoing OT demonstrate increased gum inflammation, tooth discolorations, and higher levels of inflammatory markers in the saliva and gum fluid samples compared to patients with normal BMI? This study will include 2 study groups (patients with increased BMI-test group, and normal weight patients-control group). The participants will be asked to complete a study questionnaire, which will collect information regarding their demographics, their family socioeconomic and educational status, dietary habits, and oral health-related quality of life. The participants will also receive an oral examination (evaluation of their gum health), and they will have their intraoral photos taken, as well as an impression of their lower teeth (to create dental models). A saliva sample will be obtained by asking patients to passively "drool" in a tube, and a gingival fluid sample will be collected from the gums of the lower anterior teeth using thin paper strips. All these study procedures will be conducted at baseline (T1: before bonding of braces), and at an approximately 6-month follow-up visit (T2). Comparisons of these outcomes will be conducted between the two groups and across timepoints.
CONDITIONS
Official Title
Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged 12 to 17 years old
- Scheduled for fixed orthodontic treatment with metal braces on both dental arches for at least 6 months
- Increased BMI of 25.0 Kg/m2 or higher (test group)
- Normal BMI between 18.5 and 24.99 Kg/m2 (control group)
- Presence of all six mandibular anterior teeth with mild to moderate crowding less than 7.5 mm
- Signed assent/permission from patients and parents or guardians
You will not qualify if you...
- Habitual use of tobacco products
- Medical diseases including liver diseases, blood disorders, cardiovascular diseases, HIV, diabetes mellitus, and viral infections
- Craniofacial syndromes or cleft lip and palate
- Pregnant or lactating females
- Edentulous individuals (missing all teeth)
- Active or history of periodontitis
- Surgical or non-surgical periodontal therapy within the past 6 months
- Physical or mental disabilities preventing informed consent or assent
- Use of antibiotics, steroids, non-steroidal anti-inflammatory drugs, or antimicrobial mouth-rinses within the past 3 months
- Requirement for prophylactic antibiotics before dental procedures
- Underweight patients with BMI less than 18.5 Kg/m2
- Oral mucosal lesions such as median rhomboid glossitis or lichen planus
- Clinically visible carious teeth
AI-Screening
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Trial Site Locations
Total: 1 location
1
Eastman Institute for Oral Health, University of Rochester
Rochester, New York, United States, 14620
Actively Recruiting
Research Team
D
Dimitrios Michelogiannakis, DDS, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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