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

Browse trials for

• Obesity 6,296
• Overweight 3,670

Keywords

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

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 52 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Study population

Groups and cohorts

• 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 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)

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

   Dental casts made from alginate impressions will be analyzed using a digital caliper (accuracy 0.01 mm). The sum of the linear displacements between the anatomic contact points of the mandibular incisors (five measurements) yields Little's Irregularity Index. Higher values indicate greater misalignment.

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

6. Mean Change in Salivary Proinflammatory Biomarker Concentrations (IL-1β, IL-6, TNF-α, Leptin, Resistin)

   Salivary and gingival crevicular fluid samples will be centrifuged and analyzed using multiplexed magnetic bead assays (Milliplex MAP). Concentrations will be calculated from standard curves. Higher levels indicate greater inflammatory activity.

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

7. Mean Change in Dietary Habits Score

   Participants will complete a standardized questionnaire assessing dietary habits related to oral health and obesity. Responses will be scored to produce a composite dietary habits score; higher scores indicate less healthy dietary patterns.

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

8. Mean Change in Oral Health-Related Quality of Life (OHIP-14 Total Score)

   The Oral Health Impact Profile-14 (OHIP-14) questionnaire will assess functional limitation, pain, and psychological and social impacts of oral health. Scores from 14 items are summed (range 0-56); higher scores indicate poorer oral health-related quality of life.

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

Individual participant data

Plan to share: No — IPD will not be shared due to privacy concerns and the risk of re-identification, even with de-identified datasets. Additionally, the scope of consent obtained from participants during the trial does not include provisions for public sharing of individual-level data.