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

NCT07217756 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 52

Last updated 2025-10-20

No results posted yet for this study

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 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

  • Obesity & Overweight
  • Orthodontic Treatment

Sponsors & Collaborators

  • American Association of Orthodontists Foundation

    collaborator UNKNOWN

  • University of Rochester

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2026-11-01
Completion
2026-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217756 on ClinicalTrials.gov