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

Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet Before and After Treatment With a Mandibular Advancement Device (MAD)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Overjet, Dental
• Intervention / Treatment: Device: Orthodontic treatment with functional appliance (MAD)

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • University of Copenhagen, Department of Odontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Children with large overjet; Overjet ≥6 mm, planned orthodontic treatment with functional appliance	Device: Orthodontic treatment with functional appliance (MAD); Expansion plate and z-activator (MAD)
No Intervention: Control group; Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acoustic pharyngometry	Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.	Baseline
Acoustic pharyngometry	Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.	4-8 months from baseline (after expansion plate)
Acoustic pharyngometry	Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.	14-18 months from baseline (after z-activator (MAD))
Acoustic rhinometry	Calculated resistance (cm H2O/L/min) Volume of the nasal cavity (cm3) Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.	Baseline
Acoustic rhinometry	Calculated resistance (cm H2O/L/min) Volume of the nasal cavity (cm3) Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.	4-8 months from baseline (after expansion plate)
Acoustic rhinometry	Calculated resistance (cm H2O/L/min) Volume of the nasal cavity (cm3) Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.	14-18 months from baseline (after z-activator (MAD))
Cephalometric x-ray	Performed in study group before and after treatment to calculate the upper airway dimensions (cm^2). Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall Results adjusted for height and weight and compared over time.	Baseline
Cephalometric x-ray	Performed in study group before and after treatment to calculate the upper airway dimensions (cm^2). Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall Results adjusted for height and weight and compared over time.	14-18 months from baseline (after z-activator (MAD))
Cone-Beam Computed Tomography	Performed in study group before and after treatment to calculate the upper airway dimensions (cm^3). Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall; Lateral: Respective pharyngeal walls Results adjusted for height and weight and compared over time.	Baseline
Cone-Beam Computed Tomography	Performed in study group before and after treatment to calculate the upper airway dimensions (cm^3). Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall; Lateral: Respective pharyngeal walls Results adjusted for height and weight and compared over time.	14-18 months from baseline (after z-activator (MAD))

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental occlusion	3D imaging dental scanning. Width and height of the palate (mm) between upper canines and upper first molars. Results adjusted for height and weight and compared between the groups, and within the groups over time.	Baseline
Dental occlusion	3D imaging dental scanning. Width and height of the palate (mm) between upper canines and upper first molars. Results adjusted for height and weight and compared between the groups, and within the groups over time.	4-8 months from baseline (after expansion plate)
Dental occlusion	3D imaging dental scanning. Width and height of the palate (mm) between upper canines and upper first molars. Results adjusted for height and weight and compared between the groups, and within the groups over time.	14-18 months from baseline (after z-activator (MAD))
Nordic Orofacial Test-Screening	The interview part focuses on 'sensory function', 'breathing', 'habits', 'chewing/swallowing', 'drooling' and 'dryness of the mouth'; and the examination part focuses on 'face at rest', 'nose breathing', 'facial expression', 'masticatory muscle and jaw function', 'oral motor function' and 'speech'. The NOT-S results in a score from 0 to 12; and the larger NOT-S score, the severe orofacial dysfunction and reverse.	Baseline
Nordic Orofacial Test-Screening	The interview part focuses on 'sensory function', 'breathing', 'habits', 'chewing/swallowing', 'drooling' and 'dryness of the mouth'; and the examination part focuses on 'face at rest', 'nose breathing', 'facial expression', 'masticatory muscle and jaw function', 'oral motor function' and 'speech'. The NOT-S results in a score from 0 to 12; and the larger NOT-S score, the severe orofacial dysfunction and reverse.	4-8 months from baseline (after expansion plate)
Nordic Orofacial Test-Screening	The interview part focuses on 'sensory function', 'breathing', 'habits', 'chewing/swallowing', 'drooling' and 'dryness of the mouth'; and the examination part focuses on 'face at rest', 'nose breathing', 'facial expression', 'masticatory muscle and jaw function', 'oral motor function' and 'speech'. The NOT-S results in a score from 0 to 12; and the larger NOT-S score, the severe orofacial dysfunction and reverse.	14-18 months from baseline (after z-activator (MAD))
Bite force (BF)	BF examination done by the use of a Flöy-strand. The average of the four measurements was calculated and registered as the maximum BF in Newton (kg*m/s^2).	Baseline
Bite force (BF)	BF examination done by the use of a Flöy-strand. The average of the four measurements was calculated and registered as the maximum BF in Newton (kg*m/s^2).	4-8 months from baseline (after expansion plate)
Bite force (BF)	BF examination done by the use of a Flöy-strand. The average of the four measurements was calculated and registered as the maximum BF in Newton (kg*m/s^2).	14-18 months from baseline (after z-activator (MAD))
DC/TMD	Symptom Questionnaire' familiar symptoms related to temporomandibular joint (TMJ), regarding five different topics: 'pain', 'headache', 'jaw joint noises', 'closed locking of the jaw' and 'open locking of the jaw', was examined. Clinical examination of jaw mobility (mm), TMJ and masticatory muscles ascertained according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) using DC/TMD Axis I. On the basis of clinical DC/TMD examination and the questionnaire the diagnostic was made according to the DC/TMD and categorized in three groups: no TMD diagnosis, myofascial pain diagnosis and joint displacements diagnosis.	Baseline
DC/TMD	Symptom Questionnaire' familiar symptoms related to temporomandibular joint (TMJ), regarding five different topics: 'pain', 'headache', 'jaw joint noises', 'closed locking of the jaw' and 'open locking of the jaw', was examined. Clinical examination of jaw mobility (mm), TMJ and masticatory muscles ascertained according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) using DC/TMD Axis I. On the basis of clinical DC/TMD examination and the questionnaire the diagnostic was made according to the DC/TMD and categorized in three groups: no TMD diagnosis, myofascial pain diagnosis and joint displacements diagnosis.	4-8 months from baseline (after expansion plate)
DC/TMD	Symptom Questionnaire' familiar symptoms related to temporomandibular joint (TMJ), regarding five different topics: 'pain', 'headache', 'jaw joint noises', 'closed locking of the jaw' and 'open locking of the jaw', was examined. Clinical examination of jaw mobility (mm), TMJ and masticatory muscles ascertained according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) using DC/TMD Axis I. On the basis of clinical DC/TMD examination and the questionnaire the diagnostic was made according to the DC/TMD and categorized in three groups: no TMD diagnosis, myofascial pain diagnosis and joint displacements diagnosis.	14-18 months from baseline (after z-activator (MAD))
Chew-efficiency	Chewing time (seconds, s) of 10 gram of a standardized Granny Smith apple slice with the rind and core removed. No normal values are previously estimated.	Baseline
Chew-efficiency	Chewing time (seconds, s) of 10 gram of a standardized Granny Smith apple slice with the rind and core removed. No normal values are previously estimated.	4-8 months from baseline (after expansion plate)
Chew-efficiency	Chewing time (seconds, s) of 10 gram of a standardized Granny Smith apple slice with the rind and core removed. No normal values are previously estimated.	14-18 months from baseline (after z-activator (MAD))
Well-being	Strength and difficulties questionnaire examining well-being: emotional symptoms, conduct problems, inattention, peer relationship problems, prosocial behaviour. 25 questions with graduated score (true, partly true, not true).	Baseline
Well-being	Strength and difficulties questionnaire examining well-being: emotional symptoms, conduct problems, inattention, peer relationship problems, prosocial behaviour. 25 questions with graduated score (true, partly true, not true).	4-8 months from baseline (after expansion plate)
Well-being	Strength and difficulties questionnaire examining well-being: emotional symptoms, conduct problems, inattention, peer relationship problems, prosocial behaviour. 25 questions with graduated score (true, partly true, not true).	14-18 months from baseline (after z-activator (MAD))
Quality of life	Questionnaire KIDSCREEN-10 examining quality of life 10 questions with graduating score, higher score indicate higher quality of life	Baseline
Quality of life	Questionnaire KIDSCREEN-10 examining quality of life 10 questions with graduating score, higher score indicate higher quality of life	4-8 months from baseline (after expansion plate)
Quality of life	Questionnaire KIDSCREEN-10 examining quality of life 10 questions with graduating score, higher score indicate higher quality of life	14-18 months from baseline (after z-activator (MAD))
Height	Height without shoos in meter	Baseline
Height	Height without shoos in meter	4-8 months from baseline (after expansion plate)
Height	Height without shoos in meter	14-18 months from baseline (after z-activator (MAD))
Weight	Weight without shoos in kilograms	Baseline
Weight	Weight without shoos in kilograms	4-8 months from baseline (after expansion plate)
Weight	Weight without shoos in kilograms	14-18 months from baseline (after z-activator (MAD))
Body Mass Index	Body Mass Index (BMI= kg/m^2)	Baseline
Body Mass Index	Body Mass Index (BMI= kg/m^2)	4-8 months from baseline (after expansion plate)
Body Mass Index	Body Mass Index (BMI= kg/m^2)	14-18 months from baseline (after z-activator (MAD))

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Sygekassernes Helsefond; Københavns Kommune; The Danish Dental Association; Postgraduate Programme in Orthodontics, Copenhagen; Hørsholm Kommune; Rødovre Kommune; Hvidovre Kommune; Høje-Taastrup Kommune
• Investigators: Principal Investigator: Camilla Hansen, DDS, PhD student, Section of Orthodontics, Department of Odontology, University of Copenhagen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Strength and Difficulties Questionnaire
• KIDSCREEN-10

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: sleep; children; adolescents; dental occlusion; upper airway; overjet; jaw function
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: H-17011521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No