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

Study Overview
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Brief Summary
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This project examines sleep quality (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 quality, upper airway and jaw function are examined, and how these factors affect the children's well-being and quality of life.

Detailed Description
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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 quality, 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.

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

Conditions
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Overjet, Dental

Intervention / Treatment
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* Device: Orthodontic treatment with functional appliance (MAD)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overjet group: ANB angle ≥ 3 degrees (ANB are three marking points, which produce an angle describing the skeletal relationship between the maxilla and mandible) 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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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)) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, upper airway, dental occlusion, jaw function, overjet, children, adolescents