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

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ClinicalTrials.gov Identifier: NCT04964830
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Sponsor:
Collaborators:
Postgraduate Programme in Orthodontics, Copenhagen
Sygekassernes Helsefond
The Danish Dental Association
Københavns Kommune
Hørsholm Kommune
Rødovre Kommune
Hvidovre Kommune
Høje-Taastrup Kommune
Information provided by (Responsible Party):
Camilla Hansen, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Overjet, Dental Device: Orthodontic treatment with functional appliance (MAD) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
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)
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : March 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

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



Primary Outcome Measures :
  1. Presence and grade of obstructive sleep apnea [ Time Frame: Baseline ]

    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


  2. Presence and grade of obstructive sleep apnea [ Time Frame: 4-8 months from baseline (after expansion plate) ]

    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


  3. Presence and grade of obstructive sleep apnea [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    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. Oxygen desaturation index (ODI) [ Time Frame: Baseline ]
    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.

  5. Oxygen desaturation index (ODI) [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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.

  6. Oxygen desaturation index (ODI) [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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.

  7. Snore Index [ Time Frame: Baseline ]
    Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.

  8. Snore Index [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.

  9. Snore Index [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.

  10. Lowest SpO2% [ Time Frame: Baseline ]
    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%

  11. Lowest SpO2% [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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%

  12. Lowest SpO2% [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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%

  13. Average SpO2% [ Time Frame: Baseline ]
    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. Average SpO2% [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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%

  15. Average SpO2% [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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%

  16. SpO2 under 90 % [ Time Frame: Baseline ]
    Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%

  17. SpO2 under 90 % [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%

  18. SpO2 under 90 % [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%

  19. Pulse Average [ Time Frame: Baseline ]
    Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale

  20. Pulse Average [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale

  21. Pulse Average [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale

  22. Oximeter quality % [ Time Frame: Baseline ]

    Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100.

    ≥75 % is considered good


  23. Oximeter quality % [ Time Frame: 4-8 months from baseline (after expansion plate) ]

    Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100.

    ≥75 % is considered good


  24. Oximeter quality % [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100.

    ≥75 % is considered good


  25. Flow quality % [ Time Frame: Baseline ]

    Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100.

    ≥75 % is considered good


  26. Flow quality % [ Time Frame: 4-8 months from baseline (after expansion plate) ]

    Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100.

    ≥75 % is considered good


  27. Flow quality % [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100.

    ≥75 % is considered good


  28. Respiratory inductance plethysmography (RIP) quality % [ Time Frame: Baseline ]

    Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100.

    ≥75 % is considered good


  29. Respiratory inductance plethysmography (RIP) quality % [ Time Frame: 4-8 months from baseline (after expansion plate) ]

    Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100.

    ≥75 % is considered good


  30. Respiratory inductance plethysmography (RIP) quality % [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100.

    ≥75 % is considered good


  31. Estimated sleep efficiency % [ Time Frame: Baseline ]

    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


  32. Estimated sleep efficiency % [ Time Frame: 4-8 months from baseline (after expansion plate) ]

    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


  33. Estimated sleep efficiency % [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    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


  34. Respiration rate [ Time Frame: Baseline ]
    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)

  35. Respiration rate [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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)

  36. Respiration rate [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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)

  37. Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD)) [ Time Frame: Baseline ]

    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.


  38. Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD)) [ Time Frame: 4-8 months from baseline (after expansion plate) ]

    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.


  39. Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD)) [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    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.


  40. Berlin questionnaire [ Time Frame: Baseline ]

    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.


  41. Berlin questionnaire [ Time Frame: 4-8 months from baseline (after expansion plate) ]

    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.


  42. Berlin questionnaire [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    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 :
  1. Acoustic pharyngometry [ Time Frame: Baseline ]
    Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.

  2. Acoustic pharyngometry [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.

  3. Acoustic pharyngometry [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.

  4. Acoustic rhinometry [ Time Frame: Baseline ]
    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.

  5. Acoustic rhinometry [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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.

  6. Acoustic rhinometry [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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.

  7. Cephalometric x-ray [ Time Frame: Baseline ]

    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.


  8. Cephalometric x-ray [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    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.


  9. Cone-Beam Computed Tomography [ Time Frame: Baseline ]

    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.


  10. Cone-Beam Computed Tomography [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]

    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.



Other Outcome Measures:
  1. Dental occlusion [ Time Frame: Baseline ]
    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.

  2. Dental occlusion [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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.

  3. Dental occlusion [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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. Nordic Orofacial Test-Screening [ Time Frame: Baseline ]
    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.

  5. Nordic Orofacial Test-Screening [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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.

  6. Nordic Orofacial Test-Screening [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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.

  7. Bite force (BF) [ Time Frame: Baseline ]
    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).

  8. Bite force (BF) [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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).

  9. Bite force (BF) [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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).

  10. DC/TMD [ Time Frame: Baseline ]
    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.

  11. DC/TMD [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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.

  12. DC/TMD [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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.

  13. Chew-efficiency [ Time Frame: Baseline ]
    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. Chew-efficiency [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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.

  15. Chew-efficiency [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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.

  16. Well-being [ Time Frame: Baseline ]
    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).

  17. Well-being [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    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).

  18. Well-being [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    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).

  19. Quality of life [ Time Frame: Baseline ]
    KIDSCREEN-10 questionnaire examining quality of life 10 questions with graduating score, higher score indicate higher quality of life

  20. Quality of life [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    KIDSCREEN-10 questionnaire examining quality of life 10 questions with graduating score, higher score indicate higher quality of life

  21. Quality of life [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    KIDSCREEN-10 questionnaire examining quality of life 10 questions with graduating score, higher score indicate higher quality of life

  22. Height [ Time Frame: Baseline ]
    Height without shoos in meter

  23. Height [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    Height without shoos in meter

  24. Height [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    Height without shoos in meter

  25. Weight [ Time Frame: Baseline ]
    Weight without shoos in kilograms

  26. Weight [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    Weight without shoos in kilograms

  27. Weight [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    Weight without shoos in kilograms

  28. Body Mass Index [ Time Frame: Baseline ]
    Body Mass Index (BMI= kg/m^2)

  29. Body Mass Index [ Time Frame: 4-8 months from baseline (after expansion plate) ]
    Body Mass Index (BMI= kg/m^2)

  30. Body Mass Index [ Time Frame: 14-18 months from baseline (after z-activator (MAD)) ]
    Body Mass Index (BMI= kg/m^2)



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04964830


Contacts
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Contact: Camilla Hansen, DDS, PhD student 004535331724 camilla.hansen@sund.ku.dk
Contact: Liselotte Sonnesen, PhD, Professor MSO 004535326670 alson@sund.ku.dk

Locations
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Denmark
University of Copenhagen, Department of Odontology Recruiting
Copenhagen, Denmark, 2200
Contact: Camilla Hansen    004535331724    camilla.hansen@sund.ku.dk   
Contact: Liselotte Sonnesen    004535326670    alson@sund.ku.dk   
Sponsors and Collaborators
University of Copenhagen
Postgraduate Programme in Orthodontics, Copenhagen
Sygekassernes Helsefond
The Danish Dental Association
Københavns Kommune
Hørsholm Kommune
Rødovre Kommune
Hvidovre Kommune
Høje-Taastrup Kommune
Investigators
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Principal Investigator: Camilla Hansen, DDS, PhD student Section of Orthodontics, Department of Odontology, University of Copenhagen
Additional Information:
Publications:

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Responsible Party: Camilla Hansen, PhD student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04964830    
Other Study ID Numbers: H-17011521
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Camilla Hansen, University of Copenhagen:
sleep
upper airway
dental occlusion
jaw function
overjet
children
adolescents
Additional relevant MeSH terms:
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Overbite
Malocclusion, Angle Class II
Malocclusion
Tooth Diseases
Stomatognathic Diseases