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

Sponsor
University of Copenhagen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04964830
Collaborator
Postgraduate Programme in Orthodontics, Copenhagen (Other), Sygekassernes Helsefond (Other), The Danish Dental Association (Other), Københavns Kommune (Other), Hørsholm Kommune (Other), Rødovre Kommune (Other), Hvidovre Kommune (Other), Høje-Taastrup Kommune (Other)
70
1
2
47.9
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Orthodontic treatment with functional appliance (MAD)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 1, 2020
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Mar 29, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Presence and grade of obstructive sleep apnea [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 [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 [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) [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) [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) [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 [Baseline]

    Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.

  8. Snore Index [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 [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% [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% [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% [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% [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% [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% [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 % [Baseline]

    Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%

  17. SpO2 under 90 % [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 % [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 [Baseline]

    Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale

  20. Pulse Average [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 [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 % [Baseline]

    Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good

  23. Oximeter quality % [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 % [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 % [Baseline]

    Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good

  26. Flow quality % [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 % [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 % [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 % [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 % [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 % [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 % [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 % [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 [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 [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 [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)) [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)) [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)) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline]

    KIDSCREEN-10 questionnaire examining quality of life 10 questions with graduating score, higher score indicate higher quality of life

  20. Quality of life [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 [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 [Baseline]

    Height without shoos in meter

  23. Height [4-8 months from baseline (after expansion plate)]

    Height without shoos in meter

  24. Height [14-18 months from baseline (after z-activator (MAD))]

    Height without shoos in meter

  25. Weight [Baseline]

    Weight without shoos in kilograms

  26. Weight [4-8 months from baseline (after expansion plate)]

    Weight without shoos in kilograms

  27. Weight [14-18 months from baseline (after z-activator (MAD))]

    Weight without shoos in kilograms

  28. Body Mass Index [Baseline]

    Body Mass Index (BMI= kg/m^2)

  29. Body Mass Index [4-8 months from baseline (after expansion plate)]

    Body Mass Index (BMI= kg/m^2)

  30. Body Mass Index [14-18 months from baseline (after z-activator (MAD))]

    Body Mass Index (BMI= kg/m^2)

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Copenhagen, Department of Odontology Copenhagen Denmark 2200

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

  • Principal Investigator: Camilla Hansen, DDS, PhD student, Section of Orthodontics, Department of Odontology, University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Camilla Hansen, PhD student, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT04964830
Other Study ID Numbers:
  • H-17011521
First Posted:
Jul 16, 2021
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Camilla Hansen, PhD student, University of Copenhagen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2021