Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-18
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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);
Disqualifiers
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);
Trial population
Adolescent patients undergoing fixed orthodontic therapy at the Eastman Institute for Oral Health, University of Rochester, NY.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
52 Participants
are grouped into 2 trial groupsGroup A: Increased BMI group (test group)
Group B: Normal BMI group (control groups)
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)2
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.
Time frame
Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)3
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.
Time frame
Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)Secondary outcomes
1
Mean Change in Body Mass Index (BMI)
Height (cm) will be measured using a stadiometer, and weight (kg) with a calibrated digital scale. BMI will be calculated as weight (kg)/height² (m²). Measurements will be taken twice and averaged. Higher BMI indicates greater body mass relative to height.
Time frame
Baseline (T1) and approximately 6 months follow-up (T2)2
Mean Change in Full-Mouth Plaque Score (FMPS)
Plaque presence will be recorded on four surfaces per tooth (mesial, distal, buccal, lingual/palatal). The FMPS will be calculated as the percentage of surfaces with plaque present out of total surfaces examined. Higher percentages indicate poorer oral hygiene.
Time frame
Baseline (T1) and approximately 6 months follow-up (T2)3
Mean Change in Percentage of Sites with Probing Depth >3 mm
Probing depth (PD) will be measured at six sites per tooth using a periodontal probe. The percentage of sites with PD greater than 3 mm will be calculated for each participant. Higher percentages indicate more severe periodontal disease.
Time frame
Baseline (T1) and approximately 6 months follow-up (T2)4
Mean Change in Oral Dryness Score (Challacombe Scale)
Oral dryness will be assessed using the Challacombe Scale, which rates 10 indicators of xerostomia (e.g., lack of saliva pooling, frothy saliva, depapillation, fissured tongue). Scores range from 1 to 10, with 1-3 indicating mild dryness, 4-6 moderate, and 7-10 severe. Higher scores indicate greater dryness.
Time frame
Baseline (T1) and approximately 6 months follow-up (T2)Sponsors and contacts
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University of Rochester
Lead sponsor
American Association of Orthodontists Foundation
Collaborator
Source ClinicalTrials.gov