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NCT07217756 · ClinicalTrials.gov registry record
Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study
A clinical trial of Obesity & Overweight and Orthodontic Treatment, sponsored by University of Rochester.
- Recruiting
- Registry status
- 52
- Enrollment target
- 1
- Study location
NCT07217756: Recruiting study of Obesity & Overweight and Orthodontic Treatment, sponsored by University of Rochester.
NCT07217756 is a study of Obesity & Overweight and Orthodontic Treatment that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 52 participants, below the 113-participant average among 28 other Obesity & Overweight trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07217756, a study of Obesity & Overweight and Orthodontic Treatment, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- 52 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
New York
- Eastman Institute for Oral Health, University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-04-22 |
| Est. Completion | 2026-11-01 |
What NCT07217756 shows while recruiting
NCT07217756 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 113-participant average among 28 other Obesity & Overweight trials with a reported enrollment target (54% lower).
The record links to 2 conditions, with Obesity & Overweight appearing as the primary indexed condition, and to 0 interventions.
NCT07217756 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07217756 about?
NCT07217756 is a clinical study titled "Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study". 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/d...
What is the current status of trial NCT07217756?
This trial is currently recruiting. The enrollment target is 52 participants. The study started on 2022-04-22. Estimated completion is 2026-11-01.
What conditions does trial NCT07217756 study?
This clinical trial studies the following conditions: Obesity & Overweight, Orthodontic Treatment.
Who is sponsoring clinical trial NCT07217756?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217756 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07217756's enrollment target sits among peer trials
52 19th of 28 higher than 10 of 28 other Obesity & Overweight trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity & Overweight trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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