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

NCT07217756 | Recruiting

• 1 other identifier: STUDY00005905
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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. 1.Do patients with an increased BMI undergoing OT demonstrate increased microbial counts in the saliva compared to patients with normal BMI?
2. 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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Mean Change in Full-Mouth Bleeding Score (FMBS)

  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.

  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))

  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.

  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

  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.

  Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)

Secondary Outcomes (8)

• Mean Change in Body Mass Index (BMI)

  Baseline (T1) and approximately 6 months follow-up (T2)

• Mean Change in Full-Mouth Plaque Score (FMPS)

  Baseline (T1) and approximately 6 months follow-up (T2)

• Mean Change in Percentage of Sites with Probing Depth >3 mm

  Baseline (T1) and approximately 6 months follow-up (T2)

• Mean Change in Oral Dryness Score (Challacombe Scale)

  Baseline (T1) and approximately 6 months follow-up (T2)

• Mean Change in Little's Irregularity Index (Tooth Alignment)

  Baseline (T1) and approximately 6 months follow-up (T2)

Study Arms (2)

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).

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent patients undergoing fixed orthodontic therapy at the Eastman Institute for Oral Health, University of Rochester, NY.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• American Association of Orthodontists Foundation: collaborator

Study Sites (1)

Eastman Institute for Oral Health, University of Rochester

Rochester, New York, 14620, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators will collect and retain unstimulated whole salivary samples from the study participants. The investigators will also collect and retain gingival crevicular fluid samples, which will be collected with periopaper strips from the distal side of the six mandibular anterior teeth.

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dimitrios Michelogiannakis, DDS, MS

  Eastman Institute for Oral Health, University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrios Michelogiannakis, DDS, MS

CONTACT

585-275-5012; Dimitrios_Michelogiannakis@URMC.Rochester.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Program Director of the Orthodontics Department

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 16, 2025
• Study Start: April 22, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)