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

December 4, 2021 updated by: Mona Montasser, Mansoura University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35516
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Twin block
Removable Functional appliance
Device: Twin Block
Functional appliance
ACTIVE_COMPARATOR: Fixed appliance
Preadjusted fixed appliance
Device: Fixed orthodontic appliance
Braces

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharyngeal airway volume
Time Frame: One year
CBCT images will be used to measure the pharyngeal airway volume in mm3
One year
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum expiratory pressure
Time Frame: One year
Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O.
One year
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.
One year
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Mona A Montasser, Phd, Mansoura University
  • Principal Investigator: Eman S Radwan, MSc, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 10, 2019

Primary Completion (ACTUAL)

June 10, 2021

Study Completion (ACTUAL)

December 1, 2021

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 1, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 4, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A09061119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will be based on the facility regulations and approval.

IPD Sharing Time Frame

Data will be available at the end of the study i.e after 2 years.

IPD Sharing Access Criteria

Data will be available through the principle investigator and the study chair.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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