Actively Recruiting
Influence of Body Mass Index on Gum Health and Oral Microbes in Adolescents Undergoing Fixed Braces
Led by University of Rochester · Updated on 2025-10-20
52
Participants Needed
1
Research Sites
N/A
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
Researchers are studying how increased body mass index (BMI) affects oral health and orthodontic treatment outcomes in adolescents aged 12 to 18 years undergoing fixed braces therapy. The study aims to determine if higher BMI is linked to greater gum inflammation, tooth discolorations, changes in tooth alignment, and elevated inflammatory and microbial markers in saliva and gum fluid. Two groups are compared: one with increased BMI (over 25.0 Kg/m2) and a normal BMI group (18.5 to 24.99 Kg/m2). Participants will be observed at two time points: before braces are applied (baseline) and approximately six months later. During these visits, oral exams will assess gum health and tooth alignment, intraoral photos will be taken, and dental impressions will be made. Saliva and gum fluid samples will be collected to measure microbial counts and inflammatory markers. Additionally, participants will complete questionnaires about demographics, diet, and oral health quality of life. Throughout the study, researchers will measure changes in gum bleeding, white spot lesions on teeth, microbial levels of Candida albicans and Streptococcus mutans, as well as inflammatory markers and dietary habits. The study also tracks changes in body mass index and oral dryness. Safety and progression are monitored over the six-month period to understand the impact of BMI on oral health during orthodontic treatment.
CONDITIONS
Brief 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
- Scheduled for fixed orthodontic therapy on both dental arches for at least 6 months
- Increased BMI (≥25.0 Kg/m2) for test group or normal BMI (18.5 to 24.99 Kg/m2) for control group
- Presence of all six mandibular anterior teeth with mild to moderate crowding (<7.5 mm)
- Willingness of patient and parent/guardian to provide signed assent and permission
You will not qualify if you...
- Regular use of tobacco products
- Medical diseases such as liver disease, blood disorders, cardiovascular disease, HIV, diabetes, or viral infections
- Craniofacial syndromes or cleft lip and palate
- Pregnant or lactating females
- Missing teeth (edentulous)
- Active or history of periodontitis
- Recent periodontal therapy within 6 months
- Physical or mental disabilities preventing consent
- Recent use of antibiotics, steroids, anti-inflammatory drugs, or antimicrobial mouth-rinses
- Undergoing cancer therapy
- Underweight (BMI less than 18.5 Kg/m2)
- Oral mucosal lesions like median rhomboid glossitis or lichen planus
- Visible tooth decay (carious teeth)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months
Participants are observed before and after placement of fixed orthodontic braces to measure gum health, oral microbes, and other oral health indicators.
2 visits (baseline before bonding and follow-up at approximately 6 months)
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
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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