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

Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04255511

Enrollment

Registered

2020-02-05

Start date

2019-12-10

Completion date

2021-12-01

Last updated

2021-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ClassII Division 1 Malocclusion, Mandibular Retrognathism

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.

Interventions

DEVICETwin Block

Functional appliance

DEVICEFixed orthodontic appliance

Braces

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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.

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 linear (mm) skeletal, dental and soft tissue changes of maxilla and mandible.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026