Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2019
CompletedFirst Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedDecember 7, 2021
December 1, 2021
1.5 years
January 30, 2020
December 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Pharyngeal airway volume
CBCT images will be used to measure the pharyngeal airway volume in mm3
One year
Nocturnal breathing
Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.
One year
Secondary Outcomes (3)
Maximum expiratory pressure
One year
Craniofacial changes
One year
Craniofacial changes
One year
Study Arms (2)
Twin block
EXPERIMENTALRemovable Functional appliance
Fixed appliance
ACTIVE COMPARATORPreadjusted fixed appliance
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of orthodontic treatment.
- Presence of craniofacial anomalies or TMJ disorders.
- Systemic problems that may affect craniofacial growth.
- Abnormal oral habits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University
Al Mansurah, 35516, Egypt
Related Publications (1)
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.
PMID: 37522361DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mona A Montasser, Phd
Mansoura University
- PRINCIPAL INVESTIGATOR
Eman S Radwan, MSc
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Orthodontics
Study Record Dates
First Submitted
January 30, 2020
First Posted
February 5, 2020
Study Start
December 10, 2019
Primary Completion
June 10, 2021
Study Completion
December 1, 2021
Last Updated
December 7, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available at the end of the study i.e after 2 years.
- Access Criteria
- Data will be available through the principle investigator and the study chair.
Will be based on the facility regulations and approval.