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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Twin block | Experimental | Removable Functional appliance |
|
| Fixed appliance | Active Comparator | Preadjusted fixed appliance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Twin Block | Device | Functional appliance |
| |
| Fixed orthodontic appliance |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum expiratory pressure | Oral expiratory peak flow meter will be used to measure the maximum expiratory pressure as cmH2O. | One year |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona A Montasser, Phd | Mansoura University | Study Chair |
| Eman S Radwan, MSc | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37522361 | Derived | 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. |
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Will be based on the facility regulations and approval.
Data will be available at the end of the study i.e after 2 years.
Data will be available through the principle investigator and the study chair.
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| ID | Term |
|---|---|
| D000077744 | Orthodontic Appliances, Fixed |
| ID | Term |
|---|---|
| D009967 | Orthodontic Appliances |
| D009970 | Orthodontics |
| D003813 | Dentistry |
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| Device |
Braces |
|
| One year |
| Craniofacial changes | Lateral cephalometric images extracted from the CBCT images will be used to measure angular (ยบ) skeletal, dental and soft tissue changes of maxilla and mandible. | One year |