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

Not Applicable

Active, not recruiting

• Conditions: Overjet, Dental
• Interventions: Device: Orthodontic treatment with functional appliance (MAD)

• Registration Number: NCT04964830
• Lead Sponsor: University of Copenhagen

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.

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-07-13
• Study First Posted: 2021-07-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children with large overjet	Orthodontic treatment with functional appliance (MAD)	Overjet ≥6 mm, planned orthodontic treatment with functional appliance

Primary Outcome Measures

Name	Time	Method
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
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.
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
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
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.
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.
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%
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)
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%
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
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
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%
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
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

University of Copenhagen, Department of Odontology; 🇩🇰 Copenhagen, Denmark