Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet

NCT04964830 | Active Not Recruiting

• 1 other identifier: H-17011521
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Overjet, Dental

Keywords

sleep; upper airway; dental occlusion; jaw function; overjet; children; adolescents

Outcome Measures

Primary Outcomes (42)

• Presence and grade of obstructive sleep apnea

  Overnight polygraphy performed at home. Apnea: Reduction of ≥ 90 % of the oronasal airflow compared to baseline lasting for more than two breaths' duration. Hypopnea: Reduction of oronasal airflow of ≥ 30 % compared to baseline; desaturation of blood oxygen of ≥ 3% lasting for more than two breaths' duration, or association of desaturation with an arousal. Apnea-hypopnea pr hour during sleep (AHI-index) Normal: AHI \<1; mild: AHI\>1; moderate: AHI\>5; severe: AHI\>10

  Baseline

• Presence and grade of obstructive sleep apnea

  Overnight polygraphy performed at home. Apnea: Reduction of ≥ 90 % of the oronasal airflow compared to baseline lasting for more than two breaths' duration. Hypopnea: Reduction of oronasal airflow of ≥ 30 % compared to baseline; desaturation of blood oxygen of ≥ 3% lasting for more than two breaths' duration, or association of desaturation with an arousal. Apnea-hypopnea pr hour during sleep (AHI-index) Normal: AHI \<1; mild: AHI\>1; moderate: AHI\>5; severe: AHI\>10

  4-8 months from baseline (after expansion plate)

• Presence and grade of obstructive sleep apnea

  Overnight polygraphy performed at home. Apnea: Reduction of ≥ 90 % of the oronasal airflow compared to baseline lasting for more than two breaths' duration. Hypopnea: Reduction of oronasal airflow of ≥ 30 % compared to baseline; desaturation of blood oxygen of ≥ 3% lasting for more than two breaths' duration, or association of desaturation with an arousal. Apnea-hypopnea pr hour during sleep (AHI-index) Normal: AHI \<1; mild: AHI\>1; moderate: AHI\>5; severe: AHI\>10

  14-18 months from baseline (after z-activator (MAD))

• Oxygen desaturation index (ODI)

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %. ODI is the number of desaturation events (a 4% decrease in SpO2%) per hour of total sleep ODI\<1 is considered normal.

  Baseline

• Oxygen desaturation index (ODI)

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %. ODI is the number of desaturation events (a 4% decrease in SpO2%) per hour of total sleep ODI\<1 is considered normal.

  4-8 months from baseline (after expansion plate)

• Oxygen desaturation index (ODI)

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %. ODI is the number of desaturation events (a 4% decrease in SpO2%) per hour of total sleep ODI\<1 is considered normal.

  14-18 months from baseline (after z-activator (MAD))

• Snore Index

  Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.

  Baseline

• Snore Index

  Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.

  4-8 months from baseline (after expansion plate)

• Snore Index

  Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.

  14-18 months from baseline (after z-activator (MAD))

• Lowest SpO2%

  Overnight polygraphy performed at home. The lowest value of oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%

  Baseline

• Lowest SpO2%

  Overnight polygraphy performed at home. The lowest value of oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%

  4-8 months from baseline (after expansion plate)

• Lowest SpO2%

  Overnight polygraphy performed at home. The lowest value of oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%

  14-18 months from baseline (after z-activator (MAD))

• Average SpO2%

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%

  Baseline

• Average SpO2%

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%

  4-8 months from baseline (after expansion plate)

• Average SpO2%

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%

  14-18 months from baseline (after z-activator (MAD))

• SpO2 under 90 %

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%

  Baseline

• SpO2 under 90 %

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%

  4-8 months from baseline (after expansion plate)

• SpO2 under 90 %

  Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%

  14-18 months from baseline (after z-activator (MAD))

• Pulse Average

  Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale

  Baseline

• Pulse Average

  Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale

  4-8 months from baseline (after expansion plate)

• Pulse Average

  Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale

  14-18 months from baseline (after z-activator (MAD))

• Oximeter quality %

  Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good

  Baseline

• Oximeter quality %

  Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good

  4-8 months from baseline (after expansion plate)

• Oximeter quality %

  Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good

  14-18 months from baseline (after z-activator (MAD))

• Flow quality %

  Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good

  Baseline

• Flow quality %

  Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good

  4-8 months from baseline (after expansion plate)

• Flow quality %

  Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good

  14-18 months from baseline (after z-activator (MAD))

• Respiratory inductance plethysmography (RIP) quality %

  Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good

  Baseline

• Respiratory inductance plethysmography (RIP) quality %

  Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good

  4-8 months from baseline (after expansion plate)

• Respiratory inductance plethysmography (RIP) quality %

  Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good

  14-18 months from baseline (after z-activator (MAD))

• Estimated sleep efficiency %

  Overnight polygraphy performed at home. The percentage of time the child/adolescent sleep, in relation to the amount of time he/she spends in bed. Estimated sleep efficiency % = Total Sleep Time / Total Time in bed. ≥80 % is considered good/normal

  Baseline

• Estimated sleep efficiency %

  Overnight polygraphy performed at home. The percentage of time the child/adolescent sleep, in relation to the amount of time he/she spends in bed. Estimated sleep efficiency % = Total Sleep Time / Total Time in bed. ≥80 % is considered good/normal

  4-8 months from baseline (after expansion plate)

• Estimated sleep efficiency %

  Overnight polygraphy performed at home. The percentage of time the child/adolescent sleep, in relation to the amount of time he/she spends in bed. Estimated sleep efficiency % = Total Sleep Time / Total Time in bed. ≥80 % is considered good/normal

  14-18 months from baseline (after z-activator (MAD))

• Respiration rate

  Overnight polygraphy performed at home. Number of breaths per minute Normal values according to age: 18-30 (6-12 years) and 12-20 (\<12 years)

  Baseline

• Respiration rate

  Overnight polygraphy performed at home. Number of breaths per minute Normal values according to age: 18-30 (6-12 years) and 12-20 (\<12 years)

  4-8 months from baseline (after expansion plate)

• Respiration rate

  Overnight polygraphy performed at home. Number of breaths per minute Normal values according to age: 18-30 (6-12 years) and 12-20 (\<12 years)

  14-18 months from baseline (after z-activator (MAD))

• Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))

  ESS(CHAD) questionnaire: "Over the last month, how likely have you been to fall asleep while doing the listed activities?" Scale: 0 = would never fall asleep; 1 = slight chance of falling asleep; 2 = moderate chance of falling asleep; 3 = high chance of falling asleep. Interpretation of score: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.

  Baseline

• Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))

  ESS(CHAD) questionnaire: "Over the last month, how likely have you been to fall asleep while doing the listed activities?" Scale: 0 = would never fall asleep; 1 = slight chance of falling asleep; 2 = moderate chance of falling asleep; 3 = high chance of falling asleep. Interpretation of score: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.

  4-8 months from baseline (after expansion plate)

• Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))

  ESS(CHAD) questionnaire: "Over the last month, how likely have you been to fall asleep while doing the listed activities?" Scale: 0 = would never fall asleep; 1 = slight chance of falling asleep; 2 = moderate chance of falling asleep; 3 = high chance of falling asleep. Interpretation of score: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.

  14-18 months from baseline (after z-activator (MAD))

• Berlin questionnaire

  The questionnaire consists of 2 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories 1 and 2. Category 1: 5 questions. Positive score if ≥2 points Category 2: 3 questions. Positive score if ≥2 points High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.

  Baseline

• Berlin questionnaire

  The questionnaire consists of 2 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories 1 and 2. Category 1: 5 questions. Positive score if ≥2 points Category 2: 3 questions. Positive score if ≥2 points High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.

  4-8 months from baseline (after expansion plate)

• Berlin questionnaire

  The questionnaire consists of 2 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories 1 and 2. Category 1: 5 questions. Positive score if ≥2 points Category 2: 3 questions. Positive score if ≥2 points High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.

  14-18 months from baseline (after z-activator (MAD))

Secondary Outcomes (10)

• Acoustic pharyngometry

  Baseline

• Acoustic pharyngometry

  4-8 months from baseline (after expansion plate)

• Acoustic pharyngometry

  14-18 months from baseline (after z-activator (MAD))

• Acoustic rhinometry

  Baseline

• Acoustic rhinometry

  4-8 months from baseline (after expansion plate)

Other Outcomes (30)

• Dental occlusion

  Baseline

• Dental occlusion

  4-8 months from baseline (after expansion plate)

• Dental occlusion

  14-18 months from baseline (after z-activator (MAD))

Study Arms (2)

Children with large overjet

ACTIVE COMPARATOR

Overjet ≥6 mm, planned orthodontic treatment with functional appliance

Device: Orthodontic treatment with functional appliance (MAD)

Control group

NO INTERVENTION

Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment

Interventions

Orthodontic treatment with functional appliance (MAD) DEVICE

Expansion plate and z-activator (MAD)

Children with large overjet

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Copenhagen: lead
• Postgraduate Programme in Orthodontics, Copenhagen: collaborator
• Sygekassernes Helsefond: collaborator
• The Danish Dental Association: collaborator
• Københavns Kommune: collaborator
• Hørsholm Kommune: collaborator
• Rødovre Kommune: collaborator
• Hvidovre Kommune: collaborator
• Høje-Taastrup Kommune: collaborator

Study Sites (1)

University of Copenhagen, Department of Odontology

Copenhagen, 2200, Denmark

Location

Related Publications (18)

• 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.

  PMID: 27304232 BACKGROUND

• 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.

  PMID: 32389570 BACKGROUND

• 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.

  PMID: 30580193 BACKGROUND

• 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.

  PMID: 29542042 BACKGROUND

• 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.

  PMID: 29440942 BACKGROUND

• 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.

  PMID: 29142656 BACKGROUND

• 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.

  PMID: 25806863 BACKGROUND

• 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.

  PMID: 15743864 BACKGROUND

• 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.

  PMID: 9825557 BACKGROUND

• 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.

  PMID: 31680340 BACKGROUND

• 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.

  PMID: 33501761 BACKGROUND

• 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.

  PMID: 23372461 BACKGROUND

• 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.

  PMID: 33598109 BACKGROUND

• 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.

  PMID: 26541535 BACKGROUND

• 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.

  PMID: 19464658 BACKGROUND

• 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.

  PMID: 39648069 DERIVED

• 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.

  PMID: 38958059 DERIVED

• 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.

  PMID: 37661830 DERIVED

Related Links

• Strength and Difficulties Questionnaire
• KIDSCREEN-10

MeSH Terms

Conditions

Overbite; Bites and Stings

Interventions

Orthodontics

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Camilla Hansen, DDS, PhD student

  Section of Orthodontics, Department of Odontology, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: July 16, 2021
• Study Start: April 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: December 31, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)