Rapid Maxillary Expansion for Residual Pediatric

Basque Health Service16 enrolled

Overview

Randomized Controlled Trial comparing Rapid Maxillary Expansion with Standard Clinical Practice in patients with residual pediatric Obstructive Sleep Apnea Syndrome after adenotonsillectomy.

Cure rate of pediatric Obstructive Sleep Apnea Syndrome (OSAS) after gold-standard-treatment adenotonsillectomy is 50-80%. Treatment alternatives are scarce, poorly effective and based upon low scientific evidence. This means one out of five patients will remain exposed to the well-known neurocognitive, behavioral and quality of life adverse effects of disease. Rapid Maxillary Expansion, an orthopaedic-orthodontic treatment of pediatric malocclusion, has recently shown promising results in the treatment of pediatric OSAS based upon its effect on craniofacial and upper airway growth, usually limited in these patients. The investigators propose a randomized, prospective, controlled trial in patients with Pediatric OSAS non-responding to adenotonsillectomy. The aim of the study is to enhance the treatment success rate avoiding morbimortality associated to disease persistence during childhood and development during adult life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Standard clinical practicePROCEDURE

Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.

Standard clinical practice + Rapid Maxillary ExpansionDEVICE

Mid-palatal suture osteogenic distraction delivered through a self-activated acrylic intraoral device custom-fit into the children´s palate and maxillary posterior teeth providing a transverse expansion of the dentofacial skeleton.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children (boys and girls) between 4 and 9 years of age. * Residual OSAS after adenotonsillectomy (described as an Apnea Hypopnea Index over 3 objectively measured by means of polysomnography). * Rapid maxillary expansion indication. * Parents or tutors sign Informed Consent. Exclusion Criteria: * Craniofacial syndromes or neurologic disease diagnosis. * Adenoid residual hypertrophy occluding \>50% nasal airway as measured by means of nasal flexible fiberoptic endoscopy and or tonsillar residual hypertrophy \>2 as measured by direct intraoral physical exam.

Locations (1)

Marcos Fernandez-Barriales

Vitoria-Gasteiz, Alava, Spain

Outcomes

Primary Outcomes

Apnea Hypopnea Index (AHI)

Apnea Hypopnea Index (AHI) objectively measured by means of polysomnography.

Time frame: During sleep, an average of 10 hours

Secondary Outcomes

Sleep-related quality of life

Quality of life as described by OSA-18 questionnaire.

Time frame: 2 years

Craniofacial growth

Craniofacial growth by lateral cephalometric radiograph.

Time frame: 2 years

Dental arch growth

Dental arch growth as described by Moorrees et al 1969.

Time frame: 2 years

Adenotonsillar hypertrophy

Adenotonsillar hypertrophy by nasal flexible fiberoptic endoscopy.

Time frame: 2 years

Data from ClinicalTrials.gov

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