[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609682":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":25,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":10,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Increased BMI group (test group)",null,"The increased BMI group will include patients with a BMI\\>25.0 Kg\u002Fm2.",{"label":13,"type":10,"description":14,"interventionNames":10},"Normal BMI group (control groups)","The normal-BMI group will include patients with a BMI between 18.5 and 24.99 (Kg\u002Fm2).",[16],{"name":17,"affiliation":18,"role":19},"Dimitrios Michelogiannakis, DDS, MS","Eastman Institute for Oral Health, University of Rochester","PRINCIPAL_INVESTIGATOR",[21],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","585-275-5012","Dimitrios_Michelogiannakis@URMC.Rochester.edu",[26],{"facility":18,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Rochester","New York","14620","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-77.61556,43.15478,{"lat":37,"lon":36},[40,41,42,45,47,49,51,53],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},{"name":17,"role":19,"phone":10,"phoneExt":10,"email":10},{"name":43,"role":44,"phone":10,"phoneExt":10,"email":10},"Elli Anna Kotsailidi, DDS, MS","SUB_INVESTIGATOR",{"name":46,"role":44,"phone":10,"phoneExt":10,"email":10},"Paul Emile Rossouw, DDS, PhD",{"name":48,"role":44,"phone":10,"phoneExt":10,"email":10},"Luis Mendez, DDS",{"name":50,"role":44,"phone":10,"phoneExt":10,"email":10},"Ibrahim Kassem, DDS, MS",{"name":52,"role":44,"phone":10,"phoneExt":10,"email":10},"Atoosa Pahlavani, DDS, MS",{"name":54,"role":44,"phone":10,"phoneExt":10,"email":10},"Jin Xiao, DDS, PhD",{"type":19,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Dimitrios Michelogiannakis","Associate Professor, Program Director of the Orthodontics Department",[59],{"name":60,"class":61},"American Association of Orthodontists Foundation","UNKNOWN","100609682","impact-of-increased-body-mass-index-on-adolescent-fixed-orthodontic-treatment-a-prospective-longitudinal-study-100609682",false,"NCT07217756","Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study","Influence of Body Mass Index on Gingival Health, White Spot Lesions, Whole Salivary Proinflammatory Cytokine and Adipokine Profile and Candida and Streptococcus Mutans Carriage Among Adolescents Undergoing Fixed Orthodontic Therapy","Inclusion Criteria:\n\n* adolescents (12-17 years old);\n* patients scheduled to undergo comprehensive fixed orthodontic therapy (OT) (for at least 6 months with metal braces\u002Fwires) on both dental arches;\n* patients with increased BMI (≥25.0 Kg\u002Fm2) (test-Group);\n* patients with normal BMI \\[18.5-24.99 (Kg\u002Fm2)\\] (control-Group);\n* patients with all 6 mandibular anterior teeth present and mild-to-moderate mandibular crowding (\\\u003C7.5 mm);\n* patients and parents\u002Fguardians willing to provide signed assent\u002Fpermission.\n\nExclusion Criteria:\n\n* self-reported habitual tobacco product users;\n* patients with self-reported medical diseases such as hepatic diseases, blood disorders, cardiovascular diseases, HIV, diabetes mellitus, and viral infections;\n* patients with craniofacial syndromes and\u002For cleft lip and palate;\n* pregnant and\u002For lactating females (by self\u002Fparent report);\n* edentulous individuals;\n* patients with active or a history of periodontitis;\n* patients having undergone surgical and\u002For non-surgical periodontal therapy within the past 6 months;\n* patients with physical and\u002For mental\u002Fcognitive disabilities who are decisionally-impaired and not able to consent\u002Fassent for themselves;\n* patients who reported use of medications such as antibiotics, steroids (inhalers and\u002For 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;\n* patients undergoing cancer therapy;\n* underweight patients (BMI less than 18.5 Kg\u002Fm2);\n* patients with oral mucosal lesions such as median rhomboid glossitis and lichen planus;\n* patients with clinically visible carious teeth.",true,"ALL","12 Years","18 Years",{"count":74,"type":75},52,"ESTIMATED","OBSERVATIONAL","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\u002Fdiscolorations, 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:\n\n1. Do patients with an increased BMI undergoing OT demonstrate increased microbial counts in the saliva compared to patients with normal BMI?\n2. 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.",[79,80],"Obesity & Overweight","Orthodontic Treatment",[82,83,84,85,86],"body mass index","obesity","orthodontic treatment","adolescents","fixed orthodontic appliances","2025-10-15",{"date":89,"type":90},"2025-10-20","ACTUAL",{"date":92,"type":90},"2022-04-22",{"date":94,"type":75},"2026-11-01",{"name":5,"class":6},1]