Recruiting

Observational Study

Sponsor:

University of Rochester

Code:

NCT07217756

Conditions

Obesity & Overweight

Orthodontic Treatment

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Study Details

Brief 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

Study ID

NCT07217756

Start date

Apr 22, 2022

Status verified date

Oct, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

52 participants

Anticipated

Interventions and Outcome Measures

Arms

Increased BMI group (test group)

The increased BMI group will include patients with a BMI>25.0 Kg/m2.

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) ]
  • Mean Change in White Spot Lesion (WSL) Score (International Caries Detection and Assessment System (ICDAS)) [ Time Frame: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2) ]
  • Mean Change in Salivary Microbial Counts of Candida albicans and Streptococcus mutans [ Time Frame: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2) ]

Central Contacts and Locations

Central contacts

Locations

Eastman Institute for Oral Health, University of Rochester

Recruiting

Rochester, New York, United States, 14620

Contacts

Principal Investigator:

Dimitrios Michelogiannakis, DDS, MS

More Information

Sponsor

University of Rochester

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • body mass index
  • obesity
  • orthodontic treatment
  • adolescents
  • fixed orthodontic appliances

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2025-10-20.