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Completed

NCT Number: NCT04255511

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

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.

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Key information

Conditions

ClassII Division 1 Malocclusion Mandibular Retrognathism

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Skeletal class II division 1 malocclusion due to mandibular retrognathism.
  • Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥ 4.
  • 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.

Treatment and study plan

Twin Block

Device

Functional appliance

Fixed orthodontic appliance

Device

Braces

Primary outcomes

  1. Pharyngeal airway volume

    Time frame: One year

    CBCT images will be used to measure the pharyngeal airway volume in mm3

  2. 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

  1. Maximum expiratory pressure

    Time frame: One year

    Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O.

  2. Craniofacial changes

    Time frame: 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.

  3. Craniofacial changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Dec 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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