Rochester, NYNCT07217756Now EnrollingIRB Ready

Obesity & Overweight Clinical Trial in Rochester, NY

Access cutting-edge obesity & overweight treatment through this clinical trial at a research site in Rochester. Study-provided care at no cost to qualified participants.

Sponsored by University of Rochester

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Expert Care in Rochester

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IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related obesity & overweight treatment provided free

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Check if you qualify for this obesity & overweight clinical trial in Rochester, NY

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Why Participate?

  • No-Cost Study Care

  • Local to Rochester

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Rochester site if eligible
  4. 4Begin participation

About This Obesity & Overweight Study in Rochester

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.

Sponsor: University of Rochester

Who Can Participate

Inclusion Criteria

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.

Exclusion Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT07217756) has an active research site in Rochester, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Obesity & Overweight Treatment Options in Rochester, NY

If you're searching for obesity & overweight treatment options in Rochester, NY, this clinical trial (NCT07217756) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced obesity & overweight specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all obesity & overweight clinical trials near you to find additional studies recruiting in your area.

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