Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway

Not Applicable

Completed

• Conditions: Mandibular Retrognathism; ClassII Division 1 Malocclusion
• Interventions: Device: Twin Block; Device: Fixed orthodontic appliance

• Registration Number: NCT04255511
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-02-01
• Study First Posted: 2020-02-05
• Primary Completion: 2021-06-10
• Status Verified: 2021-12
• Study Completion: 2021-12-01
• Last Update Submitted: 2021-12-04
• Last Update Posted: 2021-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Skeletal class II division 1 malocclusion due to mandibular retrognathism.
2. Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥ 4.
3. Overjet ≥ 6 mm.
4. Patient in circumpubertal stage CVM2 and CVM3.

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Exclusion Criteria

1. History of orthodontic treatment.
2. Presence of craniofacial anomalies or TMJ disorders.
3. Systemic problems that may affect craniofacial growth.
4. Abnormal oral habits.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twin block	Twin Block	Removable Functional appliance
Fixed appliance	Fixed orthodontic appliance	Preadjusted fixed appliance

Primary Outcome Measures

Name	Time	Method
Pharyngeal airway volume	One year	CBCT images will be used to measure the pharyngeal airway volume in mm3
Nocturnal breathing	One year	Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.

Secondary Outcome Measures

Name	Time	Method
Maximum expiratory pressure	One year	Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O.
Craniofacial changes	One year	Lateral cephalometric images extracted from the CBCT images will be used to measure angular (º) skeletal, dental and soft tissue changes of maxilla and mandible.

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt