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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04964830
Enrollment
69
Registered
2021-07-16
Start date
2020-04-01
Completion date
2025-12-31
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overjet, Dental

Keywords

sleep, upper airway, dental occlusion, jaw function, overjet, children, adolescents

Brief summary

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.

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.

Interventions

DEVICEOrthodontic treatment with functional appliance (MAD)

Expansion plate and z-activator (MAD)

Sponsors

Postgraduate Programme in Orthodontics, Copenhagen
CollaboratorUNKNOWN
Sygekassernes Helsefond
CollaboratorOTHER
The Danish Dental Association
CollaboratorUNKNOWN
Københavns Kommune
CollaboratorOTHER
Hørsholm Kommune
CollaboratorUNKNOWN
Rødovre Kommune
CollaboratorUNKNOWN
Hvidovre Kommune
CollaboratorUNKNOWN
Høje-Taastrup Kommune
CollaboratorUNKNOWN
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
Yes

Inclusion criteria

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)

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.

Design outcomes

Primary

MeasureTime frameDescription
Berlin questionnaireBaselineThe 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.
Presence and grade of obstructive sleep apneaBaselineOvernight 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)BaselineOvernight 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 IndexBaselineOvernight polygraphy performed at home. Snore Index %= time spent snoring / total time spent in bed.
Lowest SpO2%BaselineOvernight 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%BaselineOvernight 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 %BaselineOvernight polygraphy performed at home. Oxygen saturation (SpO2%) measured in %; the optimal values are 94-100%
Pulse AverageBaselineOvernight polygraphy performed at home. Average of the pulse during the total sleep Continuous scale
Oximeter quality %BaselineOvernight polygraphy performed at home. Oximeter signal quality in % from 0-100. ≥75 % is considered good
Flow quality %BaselineOvernight polygraphy performed at home. Nasal cannula flow signal quality in % from 0-100. ≥75 % is considered good
Respiratory inductance plethysmography (RIP) quality %BaselineOvernight polygraphy performed at home. Thoracic and abdominal signal quality in % from 0-100. ≥75 % is considered good
Estimated sleep efficiency %BaselineOvernight 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 rateBaselineOvernight 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))BaselineESS(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.

Secondary

MeasureTime frameDescription
Acoustic pharyngometryBaselineVolumen of mouth/pharynx measured in volume cm3 Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Acoustic rhinometryBaselineCalculated resistance (cm H2O/L/min) Volume of the nasal cavity (cm3) Minimum cross-sectional area (MCA) measured in cm2 Distance to MCA in cm.
Cephalometric x-rayBaselinePerformed in study group before and after treatment to calculate the upper airway dimensions (cm\^2). Margins: Superior: Hard and soft palate; Inferior: Vallecula (plane of the hyoid bone; base of the epiglottis); Anterior: Circumvallate papillae and the oropharyngeal isthmus; Posterior: Respective pharyngeal wall Results adjusted for height and weight and compared over time.
Cone-Beam Computed TomographyBaselinePerformed 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

MeasureTime frameDescription
Chew-efficiencyBaselineChewing 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.
Well-beingBaselineStrength 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).
Quality of lifeBaselineQuestionnaire KIDSCREEN-10 examining quality of life 10 questions with graduating score, higher score indicate higher quality of life
Dental occlusionBaseline3D 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.
WeightBaselineWeight without shoos in kilograms
Body Mass IndexBaselineBody Mass Index (BMI= kg/m\^2)
HeightBaselineHeight without shoos in meter
Nordic Orofacial Test-ScreeningBaselineThe 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.
Bite force (BF)BaselineBF 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).
DC/TMDBaselineSymptom 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026