Efficacy of a Mandibular Advancement Appliance on Sleep Disordered Breathing in Children: A Study Protocol of a Crossover Randomized Controlled Trial

Abstract

Background: Sleep-Disordered Breathing (SDB) varies from habitual snoring to partial or complete obstruction of the upper airway and can be found in up to 10% of children. SDB can significantly affect children's wellbeing, as it can cause growth disorders, educational and behavioral problems, and even life-threatening conditions, such as cardiorespiratory failure. Adenotonsillectomy represents the primary treatment for pediatric SDB where adeno-tonsillar hypertrophy is indicated. For those with craniofacial anomalies, or for whom adenotonsillectomy or other treatment modalities have failed, or surgery is contra-indicated, mandibular advancement splints (MAS) may represent a viable treatment option. Whilst the efficacy of these appliances has been consistently demonstrated in adults, there is little information about their effectiveness in children.Aims: To determine the efficacy of mandibular advancement appliances for the management of SDB and related health problems in children.Methods/design: The study will be designed as a single-blind crossover randomized controlled trial with administration of both an “Active MAS” (Twin-block) and a “Sham MAS.” Eligible participants will be children aged 8–12 years whose parents report they snore ≥3 nights per week. Sixteen children will enter the full study after confirming other inclusion criteria, particularly Skeletal class I or class II confirmed by lateral cephalometric radiograph. Each child will be randomly assigned to either a treatment sequence starting with the Active or the Sham MAS. Participants will wear the appliances for 3 weeks separated by a 2-week washout period. For each participant, home-based polysomnographic data will be collected four times; once before and once after each treatment period. The Apnea Hypopnea Index (AHI) will represent the main outcome variable. Secondary outcomes will include, snoring frequency, masseter muscle activity, sleep symptoms, quality of life, daytime sleepiness, children behavior, and nocturnal enuresis. In addition, blood samples will be collected to assess growth hormone changes.Trial registration: This study was registered in the Australian New Zealand Clinical Trials Registry (ANZCTR): [ACTRN12614001013651].

A review on the influence of rapid maxillary expansion and mandibular advancement for treating obstructive sleep apnea in children

“…Comparatively, nocturnal symptoms include enuresis, nightmares, intense sweating, snoring and episodes of apnea that impede the normal sleep cycle and hinder its restorative function [29,31]. Fatal consequences can occur in the most severe cases of OSA due to cardiorespiratory failure caused by the disease [15].…”

“…AHI is the main diagnostic criterion of OSA. It is defined as the number of apnea and hypopnea events recorded per hour of sleep [15]. AHI is obtained by PSG examination and is based on the following criteria:…”

“…Air is then directed towards the back of the pharynx [33] to keep the airway patent and facilitate optimal breathing [8]. However, children may have difficulties adhering to this treatment as they could develop intolerance [15,26] and non-compliance [34,35]. Its use in pediatric patients is limited due to concerns associated with growth abnormalities [33] and the risk of developing maxillary retrognathia over time [10,36].…”

“…OSA is diagnosed by sleep assessments such as an apnea-hypopnea index (AHI) [11,12], which is acquired by polysomnography (PSG) and proven to be the best diagnostic method for OSA [13][14][15][16].…”

Cephalometric and Pharyngometric Evaluation in Snoring Children with Sleep-Disordered Breathing and Adenotonsillar Hypertrophy Under an Orthodontic or Orthopedic Treatment

“…14 Rapid maxillary expansion has been reported to achieve improvements in respiratory function, even during sleep, and functional appliances have recently been applied in children with SDB with favorable outcomes. [15][16][17][18] Myofunctional exercises are also recommended as complementary interventions. 19 However, the effect of an orthodontic and functional orthopedic oral appliance (OOA) treatment in habitually snoring children with ATH on airway growth has not been systematically examined.…”