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This randomized clinical trial aims to evaluate and compare the effectiveness of the Quad Helix (QH) appliance versus Rapid Maxillary Expanders (RME) in treating posterior cross-bite in Egyptian children during the mixed dentition stage. The study will also assess patient comfort and pain levels associated with each appliance.
The study involves 20 orthodontic patients aged 9-12 years with posterior cross-bite. Group A will receive the Quad Helix appliance, while Group B will receive Rapid Maxillary Expanders. Evaluation will be based on orthodontic study models, clinical photographs, and various radiographs including CBCT. Treatment will continue until complete correction is achieved, followed by a 3-month passive retention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A:Quad Helix Appliance | Experimental | Participants in this group will receive treatment using a fixed Quad Helix (QH) appliance to correct posterior cross-bite. The appliance is fabricated using stainless steel wire and soldered to bands on the upper first permanent molars. |
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| Group B: Rapid maxillary expanders | Active Comparator | Participants in this group will receive treatment using fixed Rapid Maxillary Expanders (RME) bonded on the upper first permanent molars and pre-molars |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quad Helix(QH) Appliance | Device | It is a fixed orthodontic appliance fabricated using stainless-steel wire and soldered to bands on upper first permanent molars. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maxillary Arch Width Changes | Measured on dental castes at the level of inter molar / inter canine width and Cone-beam computed tomography (CBCT) for upper arch | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment duration | At the time of complete cross-bite correction (average of 6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science | Contact | +201026896894 | +201155874709 | moustafagalal.1.209@azhar.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Al Dany Atwa Mohamed, Professor | Faculty of dental medicine(boys) Cairo ,Al Azhar University | Study Chair |
| Mahmoud Mohamed Fathy Abo ELMahasen, Associated Professor | Faculty of dental medicine(boys) Cairo ,Al Azhar University |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dental medicine (boys) ,Cairo,Al-Azhar University | Cairo | Cairo Governorate | 00000 | Egypt |
IPD will not be shared to maintain participant confidentiality and because the data is proprietary to the Orthodontic Department at Al-Azhar University.
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A randomized controlled clinical trial with two parallel groups. Patients are randomly assigned to either receive the Quad Helix appliance (Group A) or the Rapid Maxillary Expander (Group B)
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It is an open-label study where both the participants and investigators are aware of the assigned intervention due to the nature of the orthodontic appliances used
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| Rapid Maxillary Expanders | Device | It is a fixed expansion device bonded on the upper first permanent molars and pre-molars. Activation is done at a rate of 0.25 mm twice daily (two turns per day) |
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