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| ID | Type | Description | Link |
|---|---|---|---|
| Ahmed | Other Identifier | AlAzhar | |
| lecturer | Registry Identifier | Ahmed Abo Elnour |
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| Name | Class |
|---|---|
| World Health Organization | OTHER |
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Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).
Abstract Aim of the study: To compare radiographically the morphometric changes in the nasal airway after using three types of rapid maxillary expansion (RME) conventional hyrax (CH), hybrid hyrax (HH) and maxillary skeletal expander (MSE) using cone beam computed tomography (CBCT).
Material and Methods: A total sample of thirty CBCT of patients presented with constricted maxilla with mean age of 14±3Y was randomized in to three groups. Group 1 CH, group 2 HH and group 3 MSE.
CBCT records were taken before(T1) and after six months (T2) of RME; the Airway was segmented and quantified using software (version 5.3.4.39USA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional hyrax | Active Comparator | CH 4 BANDS for expansion of maxilla and observation improvement of the air way |
|
| Hybrid hyrax | Active Comparator | HH 2 BANDS for expansion of maxilla and observation improvement of the air way |
|
| Maxillary skeletal expander | Active Comparator | MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CH 4 band | Device | expansion of maxilla and observation improvement of the air way |
|
| Measure | Description | Time Frame |
|---|---|---|
| Molar Distance: | distance in milimeter from mesiolingual cusp of upper first molar in one side to mesiolingual cusp of upper first molar in the other CBCT Measurements software | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Molar Inclination | amount of degree of Molar inclination change before and after maxillary expansion which measured from the long axis of upper first molar to palatal plane by CBCT Evaluation | 6 months |
| Maxillary Width |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shendy | Al-Azhar University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19852655 | Background | Gracco A, Malaguti A, Lombardo L, Mazzoli A, Raffaeli R. Palatal volume following rapid maxillary expansion in mixed dentition. Angle Orthod. 2010 Jan;80(1):153-9. doi: 10.2319/010407-7.1. | |
| 16448254 | Result | Lagravere MO, Major PW, Flores-Mir C. Long-term skeletal changes with rapid maxillary expansion: a systematic review. Angle Orthod. 2005 Nov;75(6):1046-52. doi: 10.1043/0003-3219(2005)75[1046:LSCWRM]2.0.CO;2. |
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CBCT Measurements
6 months
Constricted maxilla
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orthodontic department al-azhar university
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Hyrax | CH 4 BANDS for expansion of maxilla and observation improvement of the air way CH 4 band: expansion of maxilla and observation improvement of the air way |
| FG001 | Hybrid Hyrax | HH 2 BANDS for expansion of maxilla and observation improvement of the air way HH 2 bands: expansion of maxilla and observation improvement of the air way |
| FG002 | Maxillary Skeletal Expander | MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way MSE 2 bands and 4: expansion of maxilla and observation improvement of the air way |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Hyrax | CH 4 BANDS for expansion of maxilla and observation improvement of the air way CH 4 band: expansion of maxilla and observation improvement of the air way |
| BG001 | Hybrid Hyrax |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | dropout due to bad oral hygiene |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Molar Distance: | distance in milimeter from mesiolingual cusp of upper first molar in one side to mesiolingual cusp of upper first molar in the other CBCT Measurements software | Posted | Mean | Standard Deviation | mm | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Hyrax | CH 4 BANDS for expansion of maxilla and observation improvement of the air way CH 4 band: expansion of maxilla and observation improvement of the air way |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| metabolism | Metabolism and nutrition disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr. mohamed shendy | al-azhar university | 01223303833 | Shendy_ortho@azhar.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2022 | Apr 23, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2024 | Dec 24, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D063173 | Retrognathia |
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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| HH 2 bands | Device | expansion of maxilla and observation improvement of the air way |
|
| MSE 2 bands and 4 | Device | expansion of maxilla and observation improvement of the air way |
|
amount of maxillary width changes by CBCT Evaluation
| 6 months |
| Temporomandibular Joint | CBCT Evaluation | 6 months |
HH 2 BANDS for expansion of maxilla and observation improvement of the air way
HH 2 bands: expansion of maxilla and observation improvement of the air way
| BG002 | Maxillary Skeletal Expander | MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way MSE 2 bands and 4: expansion of maxilla and observation improvement of the air way |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 |
| Maxillary Skeletal Expander |
MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way MSE 2 bands and 4: expansion of maxilla and observation improvement of the air way |
|
|
| Secondary | Molar Inclination | amount of degree of Molar inclination change before and after maxillary expansion which measured from the long axis of upper first molar to palatal plane by CBCT Evaluation | Posted | Mean | Standard Deviation | mm | 6 months |
|
|
|
| Secondary | Maxillary Width | amount of maxillary width changes by CBCT Evaluation | Not Posted | 6 months | Participants |
| Secondary | Temporomandibular Joint | CBCT Evaluation | Not Posted | 6 months | Participants |
| 15 |
| 18 |
| 1 |
| 18 |
| 1 |
| 18 |
| EG001 | Hybrid Hyrax | HH 2 BANDS for expansion of maxilla and observation improvement of the air way HH 2 bands: expansion of maxilla and observation improvement of the air way | 15 | 18 | 1 | 18 | 1 | 18 |
| EG002 | Maxillary Skeletal Expander | MSE 2 BANDS AND 4 for expansion of maxilla and observation improvement of the air way MSE 2 bands and 4: expansion of maxilla and observation improvement of the air way | 16 | 18 | 1 | 18 | 2 | 18 |
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| D019465 |
| Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009057 | Stomatognathic Diseases |
| D008336 | Mandibular Diseases |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|