NCT07217756Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. okt. 20. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 52 (tervezett)
- Első benyújtás
- 2025. okt. 15.
- Kezdés
- 2022. ápr. 22.
- Elsődleges befejezés
- 2026. nov. 1.
- Fő szponzor
- University of Rochester
- Betegségek
- Elhízás
- NCT-szám
- NCT07217756
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 52
- 2022. ápr. 22. és az elsődleges befejezés (2026. nov. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- patients having undergone surgical and/or non-surgical periodontal therapy within the past 6 months;
- 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;
Más betegség
- 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;
- patients with active or a history of periodontitis;
- patients undergoing cancer therapy;
Egyéb
- self-reported habitual tobacco product users;
- pregnant and/or lactating females (by self/parent report);
- edentulous individuals;
- patients with physical and/or mental/cognitive disabilities who are decisionally-impaired and not able to consent/assent for themselves;
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 12 év – 18 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Eastman Institute for Oral Health, University of Rochester | Rochester | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.