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

NCT ID: NCT04255511

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2021-12-01

Brief Summary

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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

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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.

Conditions

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ClassII Division 1 Malocclusion Mandibular Retrognathism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Twin block

Removable Functional appliance

Group Type EXPERIMENTAL

Twin Block

Intervention Type DEVICE

Functional appliance

Fixed appliance

Preadjusted fixed appliance

Group Type ACTIVE_COMPARATOR

Fixed orthodontic appliance

Intervention Type DEVICE

Braces

Interventions

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Twin Block

Functional appliance

Intervention Type DEVICE

Fixed orthodontic appliance

Braces

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mona Montasser

Professor of Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mona A Montasser, Phd

Role: STUDY_CHAIR

Mansoura University

Eman S Radwan, MSc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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Radwan ES, Maher A, Montasser MA. Effect of functional appliances on sleep-disordered breathing in Class II division 1 malocclusion children: Randomized controlled trial. Orthod Craniofac Res. 2024 Feb;27(1):126-138. doi: 10.1111/ocr.12696. Epub 2023 Jul 31.

Reference Type DERIVED
PMID: 37522361 (View on PubMed)

Other Identifiers

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A09061119

Identifier Type: -

Identifier Source: org_study_id

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