Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway
Primary Purpose
ClassII Division 1 Malocclusion, Mandibular Retrognathism
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Twin Block
Fixed orthodontic appliance
Sponsored by
About this trial
This is an interventional treatment trial for ClassII Division 1 Malocclusion
Eligibility Criteria
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.
Sites / Locations
- Mansoura University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Twin block
Fixed appliance
Arm Description
Removable Functional appliance
Preadjusted fixed appliance
Outcomes
Primary Outcome Measures
Pharyngeal airway volume
CBCT images will be used to measure the pharyngeal airway volume in mm3
Nocturnal breathing
Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.
Secondary Outcome Measures
Maximum expiratory pressure
Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O.
Craniofacial changes
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.
Craniofacial changes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04255511
Brief Title
Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway
Official Title
Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ClassII Division 1 Malocclusion, Mandibular Retrognathism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Twin block
Arm Type
Experimental
Arm Description
Removable Functional appliance
Arm Title
Fixed appliance
Arm Type
Active Comparator
Arm Description
Preadjusted fixed appliance
Intervention Type
Device
Intervention Name(s)
Twin Block
Intervention Description
Functional appliance
Intervention Type
Device
Intervention Name(s)
Fixed orthodontic appliance
Intervention Description
Braces
Primary Outcome Measure Information:
Title
Pharyngeal airway volume
Description
CBCT images will be used to measure the pharyngeal airway volume in mm3
Time Frame
One year
Title
Nocturnal breathing
Description
Pulse oximeter will be used to measure Oxygen Desaturation Index (ODI) and report the number of 3% and/or 4% desaturations.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Maximum expiratory pressure
Description
Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O.
Time Frame
One year
Title
Craniofacial changes
Description
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.
Time Frame
One year
Title
Craniofacial changes
Description
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.
Time Frame
One year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona A Montasser, Phd
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eman S Radwan, MSc
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway
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