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.
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
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
69
Expansion plate and z-activator (MAD)
University of Copenhagen, Department of Odontology
Copenhagen, Denmark
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline
Oxygen desaturation index (ODI)
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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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Snore Index
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Time frame: 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.
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: 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%
Time frame: Baseline
SpO2 under 90 %
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Time frame: 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%
Time frame: 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
Time frame: Baseline
Pulse Average
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Time frame: 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
Time frame: 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
Time frame: Baseline
Oximeter quality %
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good
Time frame: 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
Time frame: 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
Time frame: Baseline
Flow quality %
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good
Time frame: 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
Time frame: 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
Time frame: Baseline
Respiratory inductance plethysmography (RIP) quality %
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14-18 months from baseline (after z-activator (MAD))
Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Time frame: Baseline
Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14-18 months from baseline (after z-activator (MAD))