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

Primary Purpose

Overjet, Dental

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Orthodontic treatment with functional appliance (MAD)
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Overjet, Dental focused on measuring sleep, upper airway, dental occlusion, jaw function, overjet, children, adolescents

Eligibility Criteria

9 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Copenhagen, Department of Odontology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Children with large overjet

Control group

Arm Description

Overjet ≥6 mm, planned orthodontic treatment with functional appliance

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

Outcomes

Primary Outcome Measures

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
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
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
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.
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.
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.
Snore Index
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Snore Index
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Snore Index
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
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%
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%
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%
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%
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%
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%
SpO2 under 90 %
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
SpO2 under 90 %
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
SpO2 under 90 %
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Pulse Average
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Pulse Average
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Pulse Average
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Oximeter quality %
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good
Oximeter quality %
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good
Oximeter quality %
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good
Flow quality %
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good
Flow quality %
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good
Flow quality %
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good
Respiratory inductance plethysmography (RIP) quality %
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good
Respiratory inductance plethysmography (RIP) quality %
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good
Respiratory inductance plethysmography (RIP) quality %
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good
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
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
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
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)
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)
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)
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 1, 2021
Last Updated
June 30, 2023
Sponsor
University of Copenhagen
Collaborators
Postgraduate Programme in Orthodontics, Copenhagen, Sygekassernes Helsefond, The Danish Dental Association, Københavns Kommune, Hørsholm Kommune, Rødovre Kommune, Hvidovre Kommune, Høje-Taastrup Kommune
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1. Study Identification

Unique Protocol Identification Number
NCT04964830
Brief Title
Sleep Quality, Upper Airway and Dental Occlusion in Children With Large Overjet
Official Title
Quality of Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet Before and After Treatment With a Mandibular Advancement Device (MAD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Postgraduate Programme in Orthodontics, Copenhagen, Sygekassernes Helsefond, The Danish Dental Association, Københavns Kommune, Hørsholm Kommune, Rødovre Kommune, Hvidovre Kommune, Høje-Taastrup Kommune

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overjet, Dental
Keywords
sleep, upper airway, dental occlusion, jaw function, overjet, children, adolescents

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with large overjet
Arm Type
Active Comparator
Arm Description
Overjet ≥6 mm, planned orthodontic treatment with functional appliance
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment
Intervention Type
Device
Intervention Name(s)
Orthodontic treatment with functional appliance (MAD)
Intervention Description
Expansion plate and z-activator (MAD)
Primary Outcome Measure Information:
Title
Presence and grade of obstructive sleep apnea
Description
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
Title
Presence and grade of obstructive sleep apnea
Description
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)
Title
Presence and grade of obstructive sleep apnea
Description
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))
Title
Oxygen desaturation index (ODI)
Description
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
Title
Oxygen desaturation index (ODI)
Description
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)
Title
Oxygen desaturation index (ODI)
Description
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))
Title
Snore Index
Description
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Time Frame
Baseline
Title
Snore Index
Description
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)
Title
Snore Index
Description
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))
Title
Lowest SpO2%
Description
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
Title
Lowest SpO2%
Description
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)
Title
Lowest SpO2%
Description
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))
Title
Average SpO2%
Description
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
Title
Average SpO2%
Description
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)
Title
Average SpO2%
Description
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))
Title
SpO2 under 90 %
Description
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Time Frame
Baseline
Title
SpO2 under 90 %
Description
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)
Title
SpO2 under 90 %
Description
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))
Title
Pulse Average
Description
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Time Frame
Baseline
Title
Pulse Average
Description
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)
Title
Pulse Average
Description
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))
Title
Oximeter quality %
Description
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good
Time Frame
Baseline
Title
Oximeter quality %
Description
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)
Title
Oximeter quality %
Description
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))
Title
Flow quality %
Description
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good
Time Frame
Baseline
Title
Flow quality %
Description
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)
Title
Flow quality %
Description
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))
Title
Respiratory inductance plethysmography (RIP) quality %
Description
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good
Time Frame
Baseline
Title
Respiratory inductance plethysmography (RIP) quality %
Description
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)
Title
Respiratory inductance plethysmography (RIP) quality %
Description
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))
Title
Estimated sleep efficiency %
Description
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
Title
Estimated sleep efficiency %
Description
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)
Title
Estimated sleep efficiency %
Description
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))
Title
Respiration rate
Description
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
Title
Respiration rate
Description
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)
Title
Respiration rate
Description
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))
Title
Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
Description
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
Title
Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
Description
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)
Title
Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
Description
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))
Title
Berlin questionnaire
Description
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
Title
Berlin questionnaire
Description
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)
Title
Berlin questionnaire
Description
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))
Secondary Outcome Measure Information:
Title
Acoustic pharyngometry
Description
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Time Frame
Baseline
Title
Acoustic pharyngometry
Description
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)
Title
Acoustic pharyngometry
Description
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))
Title
Acoustic rhinometry
Description
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
Title
Acoustic rhinometry
Description
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)
Title
Acoustic rhinometry
Description
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))
Title
Cephalometric x-ray
Description
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
Title
Cephalometric x-ray
Description
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))
Title
Cone-Beam Computed Tomography
Description
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
Title
Cone-Beam Computed Tomography
Description
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))
Other Pre-specified Outcome Measures:
Title
Dental occlusion
Description
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.
Time Frame
Baseline
Title
Dental occlusion
Description
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.
Time Frame
4-8 months from baseline (after expansion plate)
Title
Dental occlusion
Description
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.
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Nordic Orofacial Test-Screening
Description
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.
Time Frame
Baseline
Title
Nordic Orofacial Test-Screening
Description
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.
Time Frame
4-8 months from baseline (after expansion plate)
Title
Nordic Orofacial Test-Screening
Description
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.
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Bite force (BF)
Description
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).
Time Frame
Baseline
Title
Bite force (BF)
Description
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).
Time Frame
4-8 months from baseline (after expansion plate)
Title
Bite force (BF)
Description
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).
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
DC/TMD
Description
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.
Time Frame
Baseline
Title
DC/TMD
Description
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.
Time Frame
4-8 months from baseline (after expansion plate)
Title
DC/TMD
Description
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.
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Chew-efficiency
Description
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.
Time Frame
Baseline
Title
Chew-efficiency
Description
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.
Time Frame
4-8 months from baseline (after expansion plate)
Title
Chew-efficiency
Description
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.
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Well-being
Description
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).
Time Frame
Baseline
Title
Well-being
Description
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).
Time Frame
4-8 months from baseline (after expansion plate)
Title
Well-being
Description
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).
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Quality of life
Description
Questionnaire KIDSCREEN-10 examining quality of life 10 questions with graduating score, higher score indicate higher quality of life
Time Frame
Baseline
Title
Quality of life
Description
Questionnaire KIDSCREEN-10 examining quality of life 10 questions with graduating score, higher score indicate higher quality of life
Time Frame
4-8 months from baseline (after expansion plate)
Title
Quality of life
Description
Questionnaire KIDSCREEN-10 examining quality of life 10 questions with graduating score, higher score indicate higher quality of life
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Height
Description
Height without shoos in meter
Time Frame
Baseline
Title
Height
Description
Height without shoos in meter
Time Frame
4-8 months from baseline (after expansion plate)
Title
Height
Description
Height without shoos in meter
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Weight
Description
Weight without shoos in kilograms
Time Frame
Baseline
Title
Weight
Description
Weight without shoos in kilograms
Time Frame
4-8 months from baseline (after expansion plate)
Title
Weight
Description
Weight without shoos in kilograms
Time Frame
14-18 months from baseline (after z-activator (MAD))
Title
Body Mass Index
Description
Body Mass Index (BMI= kg/m^2)
Time Frame
Baseline
Title
Body Mass Index
Description
Body Mass Index (BMI= kg/m^2)
Time Frame
4-8 months from baseline (after expansion plate)
Title
Body Mass Index
Description
Body Mass Index (BMI= kg/m^2)
Time Frame
14-18 months from baseline (after z-activator (MAD))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Hansen, DDS, PhD student
Organizational Affiliation
Section of Orthodontics, Department of Odontology, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen, Department of Odontology
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://sdqinfo.org/a0.html
Description
Strength and Difficulties Questionnaire
URL
https://www.kidscreen.org/english/questionnaires/kidscreen-10-index/
Description
KIDSCREEN-10

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

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