How higher body mass index affects teens' braces, gums, and tooth health.
Influence of Body Mass Index on Gingival Health, White Spot Lesions, Whole Salivary Proinflammatory Cytokine and Adipokine Profile and Candida and Streptococcus Mutans Carriage Among Adolescents Undergoing Fixed Orthodontic Therapy
This project will test whether adolescents with higher BMI have more gum inflammation, tooth discoloration, and oral bacteria while wearing fixed braces.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 52 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT07217756 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adolescents 12–17 years old scheduled for at least six months of fixed metal-bracket orthodontic therapy on both arches with all six mandibular anterior teeth present and mild-to-moderate lower crowding, whose parents/guardians provide permission, are ideal candidates.
Not a fit: Patients outside the age or treatment criteria, those with active or a history of periodontitis, systemic diseases (such as diabetes or HIV), tobacco users, pregnant or lactating females, or those with craniofacial syndromes are unlikely to receive direct benefit from this study.
Why it matters
Potential benefit: If positive, results could help identify higher-risk teens so clinicians can provide targeted oral hygiene guidance and closer monitoring during orthodontic treatment.
How similar studies have performed: Prior adult studies have linked obesity to greater periodontal inflammation and altered oral microbiology, but this specific question in adolescents undergoing fixed orthodontics has been little studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.