Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Pharyngeal airway volume
Study Overview
Brief Summary
This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.
Detailed Description
The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Skeletal class II division 1 malocclusion due to mandibular retrognathism.
- •Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥
- •Overjet ≥ 6 mm.
- •Patient in circumpubertal stage CVM2 and CVM3.
Exclusion Criteria
- •History of orthodontic treatment.
- •Presence of craniofacial anomalies or TMJ disorders.
- •Systemic problems that may affect craniofacial growth.
- •Abnormal oral habits.
Arms & Interventions
Twin block
Removable Functional appliance
Intervention: Twin Block (Device)
Fixed appliance
Preadjusted fixed appliance
Intervention: Fixed orthodontic appliance (Device)
Outcomes
Primary Outcomes
Pharyngeal airway volume
Time Frame: One year
CBCT images will be used to measure the pharyngeal airway volume in mm3
Nocturnal breathing
Time Frame: One year
Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.
Secondary Outcomes
- Craniofacial changes(One year)
- Maximum expiratory pressure(One year)
Investigators
Mona Montasser
Professor of Orthodontics
Mansoura University