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Observational Study on BMI and Orthodontic Treatment in Teens

This study is looking at how having a higher body mass index (BMI) might affect the oral health of teenagers who are getting braces. Researchers want to see if teens with a higher BMI have more gum inflammation, tooth discoloration (white spot lesions), or different levels of certain bacteria in their saliva compared to teens with a normal BMI. They will compare these factors before braces are put on and again about six months later. This is an observational study, meaning researchers will watch and collect information without giving any specific treatment. The goal is to understand if a higher BMI could be a risk factor for oral health issues during orthodontic treatment.

Study design
This is an observational study with 52 participants, comparing teenagers with increased BMI to those with normal BMI while they undergo orthodontic treatment.
What's involved
You would have measurements taken at the start of your orthodontic treatment (before braces) and again about 6 months later, including checks for gum inflammation, tooth discoloration, and saliva samples.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 6 months after their braces are put on.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217756

Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study

Recruiting
Not specifiedAges 12–18Observational
University of Rochester
~52 participants
Updated 2025-10-20 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Change in Full-Mouth Bleeding Score (FMBS)
Measured over Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)
+2 more outcomes measured

Conditions

Obesity & Overweight
Orthodontic Treatment

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ObesityOrthodontic TreatmentOverweight

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Dimitrios Michelogiannakis, DDS, MS · PRINCIPAL_INVESTIGATOR · Eastman Institute for Oral Health, University of Rochester

Who to contact

Dimitrios Michelogiannakis, DDS, MS
[email protected]
585-275-5012
Email the study team

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Do you actually qualify for this trial?

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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.

What this trial measures

  • Mean Change in Full-Mouth Bleeding Score (FMBS)Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)

    Bleeding on probing (BOP) will be assessed dichotomously (yes/no) at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/palatal, mid-lingual/palatal, and disto-lingual/palatal) using a standardized periodontal probe by trained examiners. The full-mouth bleeding score (FMBS) will be calculated as the percentage of sites that bleed out of the total number of sites examined. Higher percentages indicate greater gingival inflammation.

  • Mean Change in White Spot Lesion (WSL) Score (International Caries Detection and Assessment System (ICDAS))Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)

    Standardized intraoral and facial photographs will be taken using calibrated camera settings and stored in Dolphin Imaging Software. Each visible tooth surface will be examined for color, texture, and cavitation changes and scored using the International Caries Detection and Assessment System (ICDAS). Code 0 = sound surface; code 2 = visible white spot lesion; codes 3-4 = localized enamel breakdown or dentin shadowing; codes 5-6 = cavitated lesions extending into dentin. Because photos are obtained without air drying, code 1 will be excluded. The average WSL score per participant will be calculated by dividing the total ICDAS score by the number of surfaces assessed. Mean change = score at T2 minus score at T1. Higher scores indicate greater enamel decalcification.

  • Mean Change in Salivary Microbial Counts of Candida albicans and Streptococcus mutansBaseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)

    Unstimulated whole saliva will be collected at baseline and follow-up. C. albicans will be cultured on CHROMagar™ Candida and confirmed via germ tube test from three colonies per sample. S. mutans will be cultured on Mitis Salivarius Bacitracin medium and identified by colony morphology. DNA-based microbial identification and oral microbiome sequencing with bioinformatics analysis will also be performed. Microbial counts will be reported per participant as colony-forming units per milliliter (CFU/mL) or relative abundance. Higher values indicate greater microbial load.