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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT07217756
Status
Recruiting
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Conditions

  • Obesity & Overweight
  • Orthodontic Treatment

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Apr 22, 2022
Status verified
Oct 2025
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
52 participants (estimated)

Arms

  • Arm: Increased BMI group (test group)
    The increased BMI group will include patients with a BMI\>25.0 Kg/m2.
  • Arm: Normal BMI group (control groups)
    The normal-BMI group will include patients with a BMI between 18.5 and 24.99 (Kg/m2).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eastman Institute for Oral Health, University of RochesterRochesterNew York14620
Dimitrios Michelogiannakis, DDS, MS
[email protected]
585-275-5012
Dimitrios Michelogiannakis, DDS, MS (PRINCIPAL_INVESTIGATOR)
Elli Anna Kotsailidi, DDS, MS (SUB_INVESTIGATOR)
Paul Emile Rossouw, DDS, PhD (SUB_INVESTIGATOR)
Luis Mendez, DDS (SUB_INVESTIGATOR)
Ibrahim Kassem, DDS, MS (SUB_INVESTIGATOR)
Atoosa Pahlavani, DDS, MS (SUB_INVESTIGATOR)
Jin Xiao, DDS, PhD (SUB_INVESTIGATOR)

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By research site
Eastman Institute for Oral Health, University of Rochester· Rochester, NY

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