دورية أكاديمية
Impact of tonsillectomy on the efficacy of Alt-RAMEC/PFM treatment protocols in children with class III malocclusion and tonsillar hypertrophy: protocol for a cluster randomised controlled trial.
| العنوان: | Impact of tonsillectomy on the efficacy of Alt-RAMEC/PFM treatment protocols in children with class III malocclusion and tonsillar hypertrophy: protocol for a cluster randomised controlled trial. |
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| المؤلفون: | Guo F; State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Department of Orthodontics, School & Hospital of Stomatology, Wuhan University, Wuhan, China., Li Q; State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Department of Orthodontics, School & Hospital of Stomatology, Wuhan University, Wuhan, China., Ngan P; Department of Orthodontics, School of Dentistry, West Virginia University, Morgantown, West Virginia, USA., Guan G; Department of Orthodontics, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Chen X; Department of Otorhinolaryngology, Head and Neck Surgery, Zhongnan Hospital of Wuhan University, Wuhan, China., Yang X; Department of Otorhinolaryngology, Head and Neck Surgery, Zhongnan Hospital of Wuhan University, Wuhan, China., Lv C; State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Department of Orthodontics, School & Hospital of Stomatology, Wuhan University, Wuhan, China., Hua F; State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Center for Dentofacial Development & Sleep Medicine, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Center for Orthodontics and Pediatric Dentistry at Optics Valley Branch, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Center for Evidence-Based Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Division of Dentistry, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK., Zhao T; State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China drhehong@whu.edu.cn zhaott1991@whu.edu.cn.; Department of Orthodontics, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Center for Dentofacial Development & Sleep Medicine, School & Hospital of Stomatology, Wuhan University, Wuhan, China., He H; State Key Laboratory of Oral & Maxillofacial Reconstruction and Regeneration, Key Laboratory of Oral Biomedicine Ministry of Education, Hubei Key Laboratory of Stomatology, School & Hospital of Stomatology, Wuhan University, Wuhan, China drhehong@whu.edu.cn zhaott1991@whu.edu.cn.; Department of Orthodontics, School & Hospital of Stomatology, Wuhan University, Wuhan, China.; Center for Dentofacial Development & Sleep Medicine, School & Hospital of Stomatology, Wuhan University, Wuhan, China. |
| المصدر: | BMJ open [BMJ Open] 2024 Jul 01; Vol. 14 (6), pp. e084703. Date of Electronic Publication: 2024 Jul 01. |
| نوع المنشور: | Journal Article; Clinical Trial Protocol |
| اللغة: | English |
| بيانات الدورية: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [London] : BMJ Publishing Group Ltd, 2011- |
| مواضيع طبية MeSH: | Tonsillectomy*/methods , Malocclusion, Angle Class III*/surgery , Malocclusion, Angle Class III*/therapy , Palatine Tonsil*/pathology , Palatine Tonsil*/surgery , Palatal Expansion Technique* , Hypertrophy*, Humans ; Child ; Female ; Extraoral Traction Appliances ; Randomized Controlled Trials as Topic ; Male ; Treatment Outcome ; Sleep Quality ; Adolescent |
| مستخلص: | Introduction: Orthodontic treatment using face mask protraction combined with an alternate rapid maxillary expansion and constriction/protraction face mask (Alt-RAMEC/PFM) protocol is effective in the early treatment of patients with class III malocclusion, but the stability of treatment outcomes represents a major concern. Previous studies have suggested that tonsillar hypertrophy can be a risk factor for class III malocclusion and tonsillectomy may prompt the normalisation of dentofacial growth. However, these studies had a low-to-moderate level of evidence. This study was designed to identify the impact of tonsillectomy before orthodontic treatment on the efficacy and stability of Alt-RAMEC/PFM protocols and the sleep quality and oral health in children with anterior crossbite and tonsillar hypertrophy. Methods and Analysis: This is a two-arm, parallel-group, superiority cluster randomised controlled trial, with four clinics randomly assigned to the surgery-first arm and the orthodontic-first arm in a 1:1 ratio. The Alt-RAMEC protocol involves alternate activation and deactivation of the expander's jet screw over 6 weeks to stimulate maxillary suture distraction. Patients will be instructed to wear the PFM for a minimum of 14 hours per day. The primary outcomes are changes in Wits appraisal and the degree of maxillary advancement from baseline to the end of orthodontic treatment. Lateral cephalometric radiographs, polysomnography, Obstructive Sleep Apnoea-18 questionnaire and Oral Health Impact Profile-14 questionnaire will be traced, collected and measured. We will recruit 96 patients intofor the study. To assess differences, repeated multilevel linear mixed modelling analyses will be used. Ethics and Dissemination: This study has been granted ethical approval by the Ethics Committee of the School & Hospital of Stomatology, Wuhan University (approval No. 2023-D10). Written informed consent will be obtained from the participants and their guardians. The results of the trial will be disseminated through academic conferences and journal publications. Trial Registration Number: ChiCTR2300078833. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.) |
| فهرسة مساهمة: | Keywords: ORAL MEDICINE; Paediatric otolaryngology; Randomized Controlled Trial; SLEEP MEDICINE |
| تواريخ الأحداث: | Date Created: 20240701 Date Completed: 20240701 Latest Revision: 20240701 |
| رمز التحديث: | 20240702 |
| DOI: | 10.1136/bmjopen-2024-084703 |
| PMID: | 38950988 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 2044-6055 |
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| DOI: | 10.1136/bmjopen-2024-084703 |