Clinical trial NCT04964830: Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet
Official title: Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet Before and After Treatment With a Mandibular Advancement Device (MAD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overjet, Dental
Keywords: sleep
upper airway
dental occlusion
jaw function
overjet
children
adolescents
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Postgraduate Programme in Orthodontics, Copenhagen
name: Sygekassernes Helsefond
name: The Danish Dental Association
name: Københavns Kommune
name: Hørsholm Kommune
name: Rødovre Kommune
name: Hvidovre Kommune
name: Høje-Taastrup Kommune
First posted: 2021-07-16
Enrollment: 69
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This project examines sleep (e.g. prevalence of obstructive sleep apnea(OSA)), dimension of upper airway, jaw function, well-being and quality of life in children with large overjet compared to a control group. In addition, the effect of treatment with a mandibular advancement device (MAD) on sleep, upper airway and jaw function are examined, and how these factors affect the children's well-being and quality of life.

Detailed description: Sleep is very important for children's growth, development and learning. The anatomy and size of the airway and position of the jaw can affect children's sleep. Children with large overjet due to a posterior position of the mandible have smaller airways compared to children with neutral occlusion. Reduced dimensions of the upper airways may increase the risk of impaired sleep quality and the sleep related breathing disorder obstructive sleep apnoea (OSA), which causes symptoms e.g. failure to thrive, irritability, behavioural disorders, fatigue, which affects the children's growth, development, and learning negatively.

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.

Eligibility criteria: Inclusion Criteria:

Overjet group:

* 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 general and/or craniofacial syndromes/diseases
* 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.

Primary outcomes:
measure: Presence and grade of obstructive sleep apnea
timeFrame: Baseline
measure: Presence and grade of obstructive sleep apnea
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Presence and grade of obstructive sleep apnea
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Oxygen desaturation index (ODI)
timeFrame: Baseline
measure: Oxygen desaturation index (ODI)
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Oxygen desaturation index (ODI)
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Snore Index
timeFrame: Baseline
measure: Snore Index
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Snore Index
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Lowest SpO2%
timeFrame: Baseline
measure: Lowest SpO2%
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Lowest SpO2%
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Average SpO2%
timeFrame: Baseline
measure: Average SpO2%
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Average SpO2%
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: SpO2 under 90 %
timeFrame: Baseline
measure: SpO2 under 90 %
timeFrame: 4-8 months from baseline (after expansion plate)
measure: SpO2 under 90 %
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Pulse Average
timeFrame: Baseline
measure: Pulse Average
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Pulse Average
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Oximeter quality %
timeFrame: Baseline
measure: Oximeter quality %
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Oximeter quality %
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Flow quality %
timeFrame: Baseline
measure: Flow quality %
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Flow quality %
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Respiratory inductance plethysmography (RIP) quality %
timeFrame: Baseline
measure: Respiratory inductance plethysmography (RIP) quality %
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Respiratory inductance plethysmography (RIP) quality %
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Estimated sleep efficiency %
timeFrame: Baseline
measure: Estimated sleep efficiency %
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Estimated sleep efficiency %
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Respiration rate
timeFrame: Baseline
measure: Respiration rate
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Respiration rate
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
timeFrame: Baseline
measure: Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Berlin questionnaire
timeFrame: Baseline
measure: Berlin questionnaire
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Berlin questionnaire
timeFrame: 14-18 months from baseline (after z-activator (MAD))
Secondary outcomes:
measure: Acoustic pharyngometry
timeFrame: Baseline
measure: Acoustic pharyngometry
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Acoustic pharyngometry
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Acoustic rhinometry
timeFrame: Baseline
measure: Acoustic rhinometry
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Acoustic rhinometry
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Cephalometric x-ray
timeFrame: Baseline
measure: Cephalometric x-ray
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Cone-Beam Computed Tomography
timeFrame: Baseline
measure: Cone-Beam Computed Tomography
timeFrame: 14-18 months from baseline (after z-activator (MAD))
Other outcomes:
measure: Dental occlusion
timeFrame: Baseline
measure: Dental occlusion
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Dental occlusion
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Nordic Orofacial Test-Screening
timeFrame: Baseline
measure: Nordic Orofacial Test-Screening
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Nordic Orofacial Test-Screening
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Bite force (BF)
timeFrame: Baseline
measure: Bite force (BF)
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Bite force (BF)
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: DC/TMD
timeFrame: Baseline
measure: DC/TMD
timeFrame: 4-8 months from baseline (after expansion plate)
measure: DC/TMD
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Chew-efficiency
timeFrame: Baseline
measure: Chew-efficiency
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Chew-efficiency
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Well-being
timeFrame: Baseline
measure: Well-being
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Well-being
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Quality of life
timeFrame: Baseline
measure: Quality of life
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Quality of life
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Height
timeFrame: Baseline
measure: Height
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Height
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Weight
timeFrame: Baseline
measure: Weight
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Weight
timeFrame: 14-18 months from baseline (after z-activator (MAD))
measure: Body Mass Index
timeFrame: Baseline
measure: Body Mass Index
timeFrame: 4-8 months from baseline (after expansion plate)
measure: Body Mass Index
timeFrame: 14-18 months from baseline (after z-activator (MAD))
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen, Department of Odontology
Study officials:
affiliation: Section of Orthodontics, Department of Odontology, University of Copenhagen
name: Camilla Hansen, DDS, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.