Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet
NCT ID: NCT04964830
Last Updated: 2024-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
69 participants
INTERVENTIONAL
2020-04-01
2025-12-31
Brief Summary
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Detailed Description
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Children with large overjet due to mandibular retrognathia in Denmark are offered orthodontic treatment in municipal dental care and are in most cases treated with a mandibular advancement device (MAD) keeping the mandible in a forward position relative to the maxilla. MADs are also used to treat adults with mild-moderate obstructive sleep apnoea while they sleep. This can reduce the number of apnoea periods by up to 75% as well as preventing daytime sleepiness.
No previous study have examined sleep, upper airway, jaw function, well-being and quality of life in children with large overjet before, during and after MAD treatment compared to a control group with normal occlusion.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Children with large overjet
Overjet ≥6 mm, planned orthodontic treatment with functional appliance
Orthodontic treatment with functional appliance (MAD)
Expansion plate and z-activator (MAD)
Control group
Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment
No interventions assigned to this group
Interventions
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Orthodontic treatment with functional appliance (MAD)
Expansion plate and z-activator (MAD)
Eligibility Criteria
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Inclusion Criteria
* Horizontal maxillary overjet ≥ 6 mm and need of orthodontic treatment according to the Danish procedure for screening the child population for malocclusion involving health risk.
* Informed consent from parent(s)/guardian(s)
Control group:
* Neutral occlusion
* No history of orthodontic treatment
* Informed consent from parent(s)/guardian(s)
Exclusion Criteria
* Known sleep disorders, included bruxism during sleep
* Chronic respiratory diseases and asthma6/12
* Adenoid vegetations, hypertrophic tonsils and significantly reduces airflow through the nose (mouth breather), which need primary treatment.
* Dysfunction of masticatory muscles and temporomandibular joint, which need primary treatment.
9 Years
14 Years
ALL
Yes
Sponsors
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Postgraduate Programme in Orthodontics, Copenhagen
UNKNOWN
Sygekassernes Helsefond
OTHER
The Danish Dental Association
UNKNOWN
Københavns Kommune
OTHER
Hørsholm Kommune
UNKNOWN
Rødovre Kommune
UNKNOWN
Hvidovre Kommune
UNKNOWN
Høje-Taastrup Kommune
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Camilla Hansen
PhD student
Principal Investigators
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Camilla Hansen, DDS, PhD student
Role: PRINCIPAL_INVESTIGATOR
Section of Orthodontics, Department of Odontology, University of Copenhagen
Locations
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University of Copenhagen, Department of Odontology
Copenhagen, , Denmark
Countries
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References
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Knappe SW, Sonnesen L. The Reliability and Influence of Body Position on Acoustic Pharyngometry and Rhinometry Outcomes. J Oral Maxillofac Res. 2020 Dec 31;11(4):e1. doi: 10.5037/jomr.2020.11401. eCollection 2020 Oct-Dec.
Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
Ahmad M, Hollender L, Anderson Q, Kartha K, Ohrbach R, Truelove EL, John MT, Schiffman EL. Research diagnostic criteria for temporomandibular disorders (RDC/TMD): development of image analysis criteria and examiner reliability for image analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jun;107(6):844-60. doi: 10.1016/j.tripleo.2009.02.023.
Hansen C, Markstrom A, Bakke M, Sonnesen L. Sleep-Disordered Breathing and Dimensions of The Maxillary Dental Arch and Hard Palate in Children With Class II and Large Overjet-A Case-Control Study. J Oral Rehabil. 2025 Mar;52(3):367-374. doi: 10.1111/joor.13911. Epub 2024 Dec 8.
Hansen C, Sonnesen L, Bakke M, Markstrom A. Prevalence of sleep-disordered breathing in children and adolescents with large horizontal maxillary overjet due to mandibular retrognathia: a case-control study. J Clin Sleep Med. 2024 Dec 1;20(12):1871-1878. doi: 10.5664/jcsm.11248.
Hansen C, Sonnesen L, Markstrom A. Signal quality of home polygraphy in children and adolescents. Acta Paediatr. 2023 Dec;112(12):2583-2588. doi: 10.1111/apa.16964. Epub 2023 Sep 4.
Anandarajah S, Dudhia R, Sandham A, Sonnesen L. Risk factors for small pharyngeal airway dimensions in preorthodontic children: A three-dimensional study. Angle Orthod. 2017 Jan;87(1):138-146. doi: 10.2319/012616-71.1. Epub 2016 Jun 15.
Abdalla Y, Brown L, Sonnesen L. Effects of a fixed functional appliance on upper airway volume: A 3-dimensional cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2020 Jul;158(1):40-49. doi: 10.1016/j.ajodo.2019.07.013. Epub 2020 May 7.
Petri N, Christensen IJ, Svanholt P, Sonnesen L, Wildschiodtz G, Berg S. Mandibular advancement device therapy for obstructive sleep apnea: a prospective study on predictors of treatment success. Sleep Med. 2019 Feb;54:187-194. doi: 10.1016/j.sleep.2018.09.033. Epub 2018 Nov 12.
Andersson H, Sonnesen L. Sleepiness, occlusion, dental arch and palatal dimensions in children attention deficit hyperactivity disorder (ADHD). Eur Arch Paediatr Dent. 2018 Apr;19(2):91-97. doi: 10.1007/s40368-018-0330-3. Epub 2018 Mar 14.
Knappe SW, Sonnesen L. Mandibular positioning techniques to improve sleep quality in patients with obstructive sleep apnea: current perspectives. Nat Sci Sleep. 2018 Feb 2;10:65-72. doi: 10.2147/NSS.S135760. eCollection 2018.
Sonnesen L, Petersson A, Berg S, Svanholt P. Pharyngeal Airway Dimensions and Head Posture in Obstructive Sleep Apnea Patients with and without Morphological Deviations in the Upper Cervical Spine. J Oral Maxillofac Res. 2017 Sep 30;8(3):e4. doi: 10.5037/jomr.2017.8304. eCollection 2017 Jul-Sep.
Anandarajah S, Abdalla Y, Dudhia R, Sonnesen L. Proposal of new upper airway margins in children assessed by CBCT. Dentomaxillofac Radiol. 2015;44(7):20140438. doi: 10.1259/dmfr.20140438. Epub 2015 Mar 25.
Sonnesen L, Bakke M. Molar bite force in relation to occlusion, craniofacial dimensions, and head posture in pre-orthodontic children. Eur J Orthod. 2005 Feb;27(1):58-63. doi: 10.1093/ejo/cjh069.
Sonnesen L, Bakke M, Solow B. Malocclusion traits and symptoms and signs of temporomandibular disorders in children with severe malocclusion. Eur J Orthod. 1998 Oct;20(5):543-59. doi: 10.1093/ejo/20.5.543.
Lin SY, Su YX, Wu YC, Chang JZ, Tu YK. Management of paediatric obstructive sleep apnoea: A systematic review and network meta-analysis. Int J Paediatr Dent. 2020 Mar;30(2):156-170. doi: 10.1111/ipd.12593. Epub 2019 Nov 22.
Fagundes NCF, Flores-Mir C. Pediatric obstructive sleep apnea-Dental professionals can play a crucial role. Pediatr Pulmonol. 2022 Aug;57(8):1860-1868. doi: 10.1002/ppul.25291. Epub 2021 Mar 1.
Jennum P, Ibsen R, Kjellberg J. Morbidity prior to a diagnosis of sleep-disordered breathing: a controlled national study. J Clin Sleep Med. 2013 Feb 1;9(2):103-8. doi: 10.5664/jcsm.2398.
Related Links
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Strength and Difficulties Questionnaire
Other Identifiers
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H-17011521
Identifier Type: -
Identifier Source: org_study_id
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