Overjet, DentalNCT04964830

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

A study testing Orthodontic treatment with functional appliance (MAD) in people with Overjet, Dental, run by University of Copenhagen at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 9 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Overjet, Dental
What is being tested?: Orthodontic treatment with functional appliance (MAD)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteDenmark
Study dates: 1 Apr 2020to 31 Dec 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Overjet group:
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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

University of Copenhagen, Department of Odontology
Copenhagen, 2200

Other trials in Denmark

About this study

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

This project examines sleep (e.g. prevalence of obstructive sleep apnea(OSA)), dimension of upper airway, jaw function, well-being and quality of life in children with large overjet compared to a control group. In addition, the effect of treatment with a mandibular advancement device (MAD) on sleep, upper airway and jaw function are examined, and how these factors affect the children's well-being and quality of life.

Read the 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, 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.

Conditions: Overjet, Dental
Being tested: Orthodontic treatment with functional appliance (MAD)
Keywords: sleep, upper airway, dental occlusion, jaw function, overjet, children, adolescents
Medical subject headings: Overbite, Bites and Stings

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Orthodontic treatment with functional appliance (MAD)Device
Expansion plate and z-activator (MAD)

Study groups in NCT04964830
Study group	Role	What they receive
Children with large overjet	Active comparator	Overjet ≥6 mm, planned orthodontic treatment with functional appliance Receives: Device: Orthodontic treatment with functional appliance (MAD)
Control group	No intervention	Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline
Presence and grade of obstructive sleep apnea
Overnight polygraphy performed at home. Apnea: Reduction of ≥ 90 % of the oronasal airflow compared to baseline lasting for more than two breaths' duration.
Hypopnea: Reduction of oronasal airflow of ≥ 30 % compared to baseline; desaturation of blood oxygen of ≥ 3% lasting for more than two breaths' duration, or association of desaturation with an arousal.
Apnea-hypopnea pr hour during sleep (AHI-index) Normal: AHI <1; mild: AHI>1; moderate: AHI>5; severe: AHI>10
Measured: 4-8 months from baseline (after expansion plate)
Presence and grade of obstructive sleep apnea
Overnight polygraphy performed at home. Apnea: Reduction of ≥ 90 % of the oronasal airflow compared to baseline lasting for more than two breaths' duration.
Hypopnea: Reduction of oronasal airflow of ≥ 30 % compared to baseline; desaturation of blood oxygen of ≥ 3% lasting for more than two breaths' duration, or association of desaturation with an arousal.
Apnea-hypopnea pr hour during sleep (AHI-index) Normal: AHI <1; mild: AHI>1; moderate: AHI>5; severe: AHI>10
Measured: 14-18 months from baseline (after z-activator (MAD))
Oxygen desaturation index (ODI)
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %. ODI is the number of desaturation events (a 4% decrease in SpO2%) per hour of total sleep ODI<1 is considered normal.
Measured: Baseline
Oxygen desaturation index (ODI)
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %. ODI is the number of desaturation events (a 4% decrease in SpO2%) per hour of total sleep ODI<1 is considered normal.
Measured: 4-8 months from baseline (after expansion plate)
Oxygen desaturation index (ODI)
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %. ODI is the number of desaturation events (a 4% decrease in SpO2%) per hour of total sleep ODI<1 is considered normal.
Measured: 14-18 months from baseline (after z-activator (MAD))
Snore Index
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Measured: Baseline
Snore Index
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Measured: 4-8 months from baseline (after expansion plate)
Snore Index
Overnight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Measured: 14-18 months from baseline (after z-activator (MAD))
Lowest SpO2%
Overnight polygraphy performed at home. The lowest value of oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Measured: Baseline
Lowest SpO2%
Overnight polygraphy performed at home. The lowest value of oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Measured: 4-8 months from baseline (after expansion plate)
Lowest SpO2%
Overnight polygraphy performed at home. The lowest value of oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Measured: 14-18 months from baseline (after z-activator (MAD))
Average SpO2%
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Measured: Baseline
Average SpO2%
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Measured: 4-8 months from baseline (after expansion plate)
Average SpO2%
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100% Normal: SpO2% =92-100%; mild: SpO2% =89-91%; moderate: SpO2% =76-85%; severe: SpO2% =≤75%
Measured: 14-18 months from baseline (after z-activator (MAD))
SpO2 under 90 %
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Measured: Baseline
SpO2 under 90 %
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Measured: 4-8 months from baseline (after expansion plate)
SpO2 under 90 %
Overnight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Measured: 14-18 months from baseline (after z-activator (MAD))
Pulse Average
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Measured: Baseline
Pulse Average
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Measured: 4-8 months from baseline (after expansion plate)
Pulse Average
Overnight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Measured: 14-18 months from baseline (after z-activator (MAD))
Oximeter quality %
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100.
≥75 % is considered good
Measured: Baseline
Oximeter quality %
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100.
≥75 % is considered good
Measured: 4-8 months from baseline (after expansion plate)
Oximeter quality %
Overnight polygraphy performed at home. Oximeter signal quality in % from 0-100.
≥75 % is considered good
Measured: 14-18 months from baseline (after z-activator (MAD))
Flow quality %
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100.
≥75 % is considered good
Measured: Baseline
Flow quality %
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100.
≥75 % is considered good
Measured: 4-8 months from baseline (after expansion plate)
Flow quality %
Overnight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100.
≥75 % is considered good
Measured: 14-18 months from baseline (after z-activator (MAD))
Respiratory inductance plethysmography (RIP) quality %
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100.
≥75 % is considered good
Measured: Baseline
Respiratory inductance plethysmography (RIP) quality %
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100.
≥75 % is considered good
Measured: 4-8 months from baseline (after expansion plate)
Respiratory inductance plethysmography (RIP) quality %
Overnight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100.
≥75 % is considered good
Measured: 14-18 months from baseline (after z-activator (MAD))
Estimated sleep efficiency %
Overnight polygraphy performed at home. The percentage of time the child/adolescent sleep, in relation to the amount of time he/she spends in bed.
Estimated sleep efficiency % = Total Sleep Time / Total Time in bed.
≥80 % is considered good/normal
Measured: Baseline
Estimated sleep efficiency %
Overnight polygraphy performed at home. The percentage of time the child/adolescent sleep, in relation to the amount of time he/she spends in bed.
Estimated sleep efficiency % = Total Sleep Time / Total Time in bed.
≥80 % is considered good/normal
Measured: 4-8 months from baseline (after expansion plate)
Estimated sleep efficiency %
Overnight polygraphy performed at home. The percentage of time the child/adolescent sleep, in relation to the amount of time he/she spends in bed.
Estimated sleep efficiency % = Total Sleep Time / Total Time in bed.
≥80 % is considered good/normal
Measured: 14-18 months from baseline (after z-activator (MAD))
Respiration rate
Overnight polygraphy performed at home. Number of breaths per minute Normal values according to age: 18-30 (6-12 years) and 12-20 (<12 years)
Measured: Baseline
Respiration rate
Overnight polygraphy performed at home. Number of breaths per minute Normal values according to age: 18-30 (6-12 years) and 12-20 (<12 years)
Measured: 4-8 months from baseline (after expansion plate)
Respiration rate
Overnight polygraphy performed at home. Number of breaths per minute Normal values according to age: 18-30 (6-12 years) and 12-20 (<12 years)
Measured: 14-18 months from baseline (after z-activator (MAD))
Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
ESS(CHAD) questionnaire: "Over the last month, how likely have you been to fall asleep while doing the listed activities?" Scale: 0 = would never fall asleep; 1 = slight chance of falling asleep; 2 = moderate chance of falling asleep; 3 = high chance of falling asleep.
Interpretation of score: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.
Measured: Baseline
Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
ESS(CHAD) questionnaire: "Over the last month, how likely have you been to fall asleep while doing the listed activities?" Scale: 0 = would never fall asleep; 1 = slight chance of falling asleep; 2 = moderate chance of falling asleep; 3 = high chance of falling asleep.
Interpretation of score: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.
Measured: 4-8 months from baseline (after expansion plate)
Epworth Sleepiness Scale for Children and Adolescents (ESS(CHAD))
ESS(CHAD) questionnaire: "Over the last month, how likely have you been to fall asleep while doing the listed activities?" Scale: 0 = would never fall asleep; 1 = slight chance of falling asleep; 2 = moderate chance of falling asleep; 3 = high chance of falling asleep.
Interpretation of score: 0-5 Lower Normal Daytime Sleepiness; 6-10 Higher Normal Daytime Sleepiness; 11-12 Mild Excessive Daytime Sleepiness; 13-15 Moderate Excessive Daytime Sleepiness; 16-24 Severe Excessive Daytime Sleepiness.
Measured: 14-18 months from baseline (after z-activator (MAD))
Berlin questionnaire
The questionnaire consists of 2 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories 1 and 2.
Category 1: 5 questions. Positive score if ≥2 points Category 2: 3 questions. Positive score if ≥2 points High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
Measured: Baseline
Berlin questionnaire
The questionnaire consists of 2 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories 1 and 2.
Category 1: 5 questions. Positive score if ≥2 points Category 2: 3 questions. Positive score if ≥2 points High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
Measured: 4-8 months from baseline (after expansion plate)
Berlin questionnaire
The questionnaire consists of 2 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories 1 and 2.
Category 1: 5 questions. Positive score if ≥2 points Category 2: 3 questions. Positive score if ≥2 points High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
Measured: 14-18 months from baseline (after z-activator (MAD))

Secondary outcomes (10)

Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Measured: Baseline
Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Measured: 4-8 months from baseline (after expansion plate)
Acoustic pharyngometry
Volumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Measured: 14-18 months from baseline (after z-activator (MAD))
Acoustic rhinometry
Calculated resistance (cm H2O/L/min) Volume of the nasal cavity (cm3) Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Measured: Baseline
Acoustic rhinometry
Calculated resistance (cm H2O/L/min) Volume of the nasal cavity (cm3) Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Measured: 4-8 months from baseline (after expansion plate)
Acoustic rhinometry
Calculated resistance (cm H2O/L/min) Volume of the nasal cavity (cm3) Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Measured: 14-18 months from baseline (after z-activator (MAD))
Cephalometric x-ray
Performed in study group before and after treatment to calculate the upper airway dimensions (cm^2).
Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall Results adjusted for height and weight and compared over time.
Measured: Baseline
Cephalometric x-ray
Performed in study group before and after treatment to calculate the upper airway dimensions (cm^2).
Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall Results adjusted for height and weight and compared over time.
Measured: 14-18 months from baseline (after z-activator (MAD))
Cone-Beam Computed Tomography
Performed in study group before and after treatment to calculate the upper airway dimensions (cm^3).
Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall; Lateral: Respective pharyngeal walls Results adjusted for height and weight and compared over time.
Measured: Baseline
Cone-Beam Computed Tomography
Performed in study group before and after treatment to calculate the upper airway dimensions (cm^3).
Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall; Lateral: Respective pharyngeal walls Results adjusted for height and weight and compared over time.
Measured: 14-18 months from baseline (after z-activator (MAD))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 202031 Dec 2025

First posted16 Jul 2021
Study start1 Apr 2020
Primary completion1 Sep 2024 (estimated)
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Overjet, DentalStudies of the same condition, open and under way.
More trials run by University of CopenhagenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04964830
Sponsor's protocol ID: H-17011521
Status last verified: Mar 2024
First submitted: 1 Jun 2021
Last updated: 15 Mar 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Anandarajah S, Dudhia R, Sandham A, Sonnesen L. Risk factors for small pharyngeal airway dimensions in preorthodontic children: A three-dimensional study. Angle Orthod. 2017 Jan;87(1):138-146. doi: 10.2319/012616-71.1. Epub 2016 Jun 15.
PubMed 27304232
Abdalla Y, Brown L, Sonnesen L. Effects of a fixed functional appliance on upper airway volume: A 3-dimensional cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2020 Jul;158(1):40-49. doi: 10.1016/j.ajodo.2019.07.013. Epub 2020 May 7.
PubMed 32389570
Petri N, Christensen IJ, Svanholt P, Sonnesen L, Wildschiodtz G, Berg S. Mandibular advancement device therapy for obstructive sleep apnea: a prospective study on predictors of treatment success. Sleep Med. 2019 Feb;54:187-194. doi: 10.1016/j.sleep.2018.09.033. Epub 2018 Nov 12.
PubMed 30580193
Andersson H, Sonnesen L. Sleepiness, occlusion, dental arch and palatal dimensions in children attention deficit hyperactivity disorder (ADHD). Eur Arch Paediatr Dent. 2018 Apr;19(2):91-97. doi: 10.1007/s40368-018-0330-3. Epub 2018 Mar 14.
PubMed 29542042
Knappe SW, Sonnesen L. Mandibular positioning techniques to improve sleep quality in patients with obstructive sleep apnea: current perspectives. Nat Sci Sleep. 2018 Feb 2;10:65-72. doi: 10.2147/NSS.S135760. eCollection 2018.
PubMed 29440942
Sonnesen L, Petersson A, Berg S, Svanholt P. Pharyngeal Airway Dimensions and Head Posture in Obstructive Sleep Apnea Patients with and without Morphological Deviations in the Upper Cervical Spine. J Oral Maxillofac Res. 2017 Sep 30;8(3):e4. doi: 10.5037/jomr.2017.8304. eCollection 2017 Jul-Sep.
PubMed 29142656
Anandarajah S, Abdalla Y, Dudhia R, Sonnesen L. Proposal of new upper airway margins in children assessed by CBCT. Dentomaxillofac Radiol. 2015;44(7):20140438. doi: 10.1259/dmfr.20140438. Epub 2015 Mar 25.
PubMed 25806863
Sonnesen L, Bakke M. Molar bite force in relation to occlusion, craniofacial dimensions, and head posture in pre-orthodontic children. Eur J Orthod. 2005 Feb;27(1):58-63. doi: 10.1093/ejo/cjh069.
PubMed 15743864
Sonnesen L, Bakke M, Solow B. Malocclusion traits and symptoms and signs of temporomandibular disorders in children with severe malocclusion. Eur J Orthod. 1998 Oct;20(5):543-59. doi: 10.1093/ejo/20.5.543.
PubMed 9825557
Lin SY, Su YX, Wu YC, Chang JZ, Tu YK. Management of paediatric obstructive sleep apnoea: A systematic review and network meta-analysis. Int J Paediatr Dent. 2020 Mar;30(2):156-170. doi: 10.1111/ipd.12593. Epub 2019 Nov 22.
PubMed 31680340
Fagundes NCF, Flores-Mir C. Pediatric obstructive sleep apnea-Dental professionals can play a crucial role. Pediatr Pulmonol. 2022 Aug;57(8):1860-1868. doi: 10.1002/ppul.25291. Epub 2021 Mar 1.
PubMed 33501761
Jennum P, Ibsen R, Kjellberg J. Morbidity prior to a diagnosis of sleep-disordered breathing: a controlled national study. J Clin Sleep Med. 2013 Feb 1;9(2):103-8. doi: 10.5664/jcsm.2398.
PubMed 23372461
Knappe SW, Sonnesen L. The Reliability and Influence of Body Position on Acoustic Pharyngometry and Rhinometry Outcomes. J Oral Maxillofac Res. 2020 Dec 31;11(4):e1. doi: 10.5037/jomr.2020.11401. eCollection 2020 Oct-Dec.
PubMed 33598109
Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
PubMed 26541535
Ahmad M, Hollender L, Anderson Q, Kartha K, Ohrbach R, Truelove EL, John MT, Schiffman EL. Research diagnostic criteria for temporomandibular disorders (RDC/TMD): development of image analysis criteria and examiner reliability for image analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jun;107(6):844-60. doi: 10.1016/j.tripleo.2009.02.023.
PubMed 19464658

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Overjet, Dental trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep, Upper Airway and Dental Occlusion in Children With Large Overjet Before and After Treatment With a Mandibular Advancement Device (MAD)
ClinicalTrials.gov ID: NCT04964830
Acronym / sponsor ID: H-17011521
Conditions: Overjet, Dental
Keywords: sleep, upper airway, dental occlusion, jaw function, overjet, children, adolescents
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 69 participants (actual)
Lead sponsor: University of CopenhagenUniversity, hospital or other
Collaborators: Postgraduate Programme in Orthodontics, Copenhagen, Sygekassernes Helsefond, The Danish Dental Association, Københavns Kommune, Hørsholm Kommune, Rødovre Kommune, Hvidovre Kommune, Høje-Taastrup Kommune
Study start: 1 Apr 2020 (actual)
Primary completion: 1 Sep 2024 (estimated)
Study completion: 31 Dec 2025 (estimated)
First posted: 16 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Children with large overjet	Active comparator	Device: Orthodontic treatment with functional appliance (MAD)Overjet ≥6 mm, planned orthodontic treatment with functional appliance
Control group	No intervention	–Neutral occlusion, no indication for orthodontic treatment, no prior orthodontic treatment

Who may qualify

Ages: 9 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

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)
Neutral occlusion
No history of orthodontic treatment
Informed consent from parent(s)/guardian(s)

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Orthodontic treatment with functional appliance (MAD)Expansion plate and z-activator (MAD)	Device	Children with large overjet

Primary outcome

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

10 secondary outcomes

Acoustic pharyngometry
Time frame: Baseline
Acoustic pharyngometry
Time frame: 4-8 months from baseline (after expansion plate)
Acoustic pharyngometry
Time frame: 14-18 months from baseline (after z-activator (MAD))
Acoustic rhinometry
Time frame: Baseline
Acoustic rhinometry
Time frame: 4-8 months from baseline (after expansion plate)
Acoustic rhinometry
Time frame: 14-18 months from baseline (after z-activator (MAD))
Cephalometric x-ray
Time frame: Baseline
Cephalometric x-ray
Time frame: 14-18 months from baseline (after z-activator (MAD))
Cone-Beam Computed Tomography
Time frame: Baseline
Cone-Beam Computed Tomography
Time frame: 14-18 months from baseline (after z-activator (MAD))

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Background: PubMed 27304232Anandarajah S, Dudhia R, Sandham A, Sonnesen L. Risk factors for small pharyngeal airway dimensions in preorthodontic children: A three-dimensional study. Angle Orthod. 2017 Jan;87(1):138-146. doi: 10.2319/012616-71.1. Epub 2016 Jun 15.
Background: PubMed 32389570Abdalla Y, Brown L, Sonnesen L. Effects of a fixed functional appliance on upper airway volume: A 3-dimensional cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2020 Jul;158(1):40-49. doi: 10.1016/j.ajodo.2019.07.013. Epub 2020 May 7.
Background: PubMed 30580193Petri N, Christensen IJ, Svanholt P, Sonnesen L, Wildschiodtz G, Berg S. Mandibular advancement device therapy for obstructive sleep apnea: a prospective study on predictors of treatment success. Sleep Med. 2019 Feb;54:187-194. doi: 10.1016/j.sleep.2018.09.033. Epub 2018 Nov 12.
Background: PubMed 29542042Andersson H, Sonnesen L. Sleepiness, occlusion, dental arch and palatal dimensions in children attention deficit hyperactivity disorder (ADHD). Eur Arch Paediatr Dent. 2018 Apr;19(2):91-97. doi: 10.1007/s40368-018-0330-3. Epub 2018 Mar 14.
Background: PubMed 29440942Knappe SW, Sonnesen L. Mandibular positioning techniques to improve sleep quality in patients with obstructive sleep apnea: current perspectives. Nat Sci Sleep. 2018 Feb 2;10:65-72. doi: 10.2147/NSS.S135760. eCollection 2018.
Background: PubMed 29142656Sonnesen L, Petersson A, Berg S, Svanholt P. Pharyngeal Airway Dimensions and Head Posture in Obstructive Sleep Apnea Patients with and without Morphological Deviations in the Upper Cervical Spine. J Oral Maxillofac Res. 2017 Sep 30;8(3):e4. doi: 10.5037/jomr.2017.8304. eCollection 2017 Jul-Sep.
Background: PubMed 25806863Anandarajah S, Abdalla Y, Dudhia R, Sonnesen L. Proposal of new upper airway margins in children assessed by CBCT. Dentomaxillofac Radiol. 2015;44(7):20140438. doi: 10.1259/dmfr.20140438. Epub 2015 Mar 25.
Background: PubMed 15743864Sonnesen L, Bakke M. Molar bite force in relation to occlusion, craniofacial dimensions, and head posture in pre-orthodontic children. Eur J Orthod. 2005 Feb;27(1):58-63. doi: 10.1093/ejo/cjh069.
Background: PubMed 9825557Sonnesen L, Bakke M, Solow B. Malocclusion traits and symptoms and signs of temporomandibular disorders in children with severe malocclusion. Eur J Orthod. 1998 Oct;20(5):543-59. doi: 10.1093/ejo/20.5.543.
Background: PubMed 31680340Lin SY, Su YX, Wu YC, Chang JZ, Tu YK. Management of paediatric obstructive sleep apnoea: A systematic review and network meta-analysis. Int J Paediatr Dent. 2020 Mar;30(2):156-170. doi: 10.1111/ipd.12593. Epub 2019 Nov 22.
Background: PubMed 33501761Fagundes NCF, Flores-Mir C. Pediatric obstructive sleep apnea-Dental professionals can play a crucial role. Pediatr Pulmonol. 2022 Aug;57(8):1860-1868. doi: 10.1002/ppul.25291. Epub 2021 Mar 1.
Background: PubMed 23372461Jennum P, Ibsen R, Kjellberg J. Morbidity prior to a diagnosis of sleep-disordered breathing: a controlled national study. J Clin Sleep Med. 2013 Feb 1;9(2):103-8. doi: 10.5664/jcsm.2398.
Strength and Difficulties QuestionnaireLink provided by the sponsor.
KIDSCREEN-10Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Camilla Hansen, DDS, PhD student principal investigator

Section of Orthodontics, Department of Odontology, University of Copenhagen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Orthodontic treatment with functional appliance (MAD) in people with Overjet, Dental, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence and grade of obstructive sleep apnea (time frame: Baseline). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04964830, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.