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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 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 125-participant average among 15 other Obesity & Overweight trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07217756
The ClinicalTrials.gov registry entry for NCT07217756 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 125-participant average among 15 other Obesity & Overweight trials with a reported enrollment target (58% lower). The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity & Overweight appearing as the primary indexed condition, and to 0 interventions.
NCT07217756 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.
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