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This randomized controlled trial is designed to compare between Fan expander with palatal springs appliance vs three-way expander regarding the their effectiveness in maxillary expansion in patients with bilateral cleft
The study provides three-dimensional expansion for cleft lip and palate patients. Patients with repaired cleft lip and/or palate have maxillary deficiency and hypoplasia in the three planes of space. Most cases have a normal buccolingual occlusal relation in the molar region between upper and lower jaws, while they manifest arch constriction at the anterior inter-canine width area as well as premaxillary collapse and anterior crossbite. Conventional expansion appliances address only the transverse discrepancy requiring a further step to re-align the premaxilla. So, the aim of the study is to compare the efficiency and the effects of the new design of the three-way palatal expander and the modified fan expander in maxillary arch development in cleft lip and palate patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three-way iMini Hyrax group | Experimental | For group (A) cases, a custom-made Three-way palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. Three mini-expansion screws with two break resistant retention legs, oriented as follows: a transverse screw and bilateral sagittal screws. |
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| Fan Expander group | Active Comparator | For group (B) cases, a custom-made modified Fan palatal expansion appliance will be made. The appliance design will be composed of: Orthodontic bands on first permanent molars. A fan expansion screw with break resistant retention legs with soldered finger springs just palatal to the premaxilla. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Maxillary Expansion with 3 expansion screws | Device | In patients requiring maxillary expansion, after randomization and allocation for each to receive which expander, appliance will be cemented. In the 3-way group (A), 3 screw activations will be delivered by the care giver to expand the maxillary arch in 3D manner correcting the collapsed arch anteriorly. |
| Measure | Description | Time Frame |
|---|---|---|
| Maxillary arch development in Anteroposterior dimension | Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms | [Time Frame: 6 - 12 months] |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-canine width expansion in the transverse plane | Inter-canine width expansion in the transverse plane measured on Digital dental models. | [Time Frame: 6- 12 months] |
| Dental changes with expansion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthodontics, Faculty of Dentistry, Ain Shams University | Cairo | Abbaseya | 11566 | Egypt |
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Parallel Assignment
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| 3D Maxillary Expansion using modified Fan expander with springs | Device | For the fan expander with palatal springs (B) , spring activation will be done by the operator after cemenation intraorally, then the care giver too will just activate one fan screw. Also 3D expansion evaluation was done. |
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Amount of dental tipping occurring with expansion and amount of expansion and distal movement of maxillary molars
| [Time Frame: 6- 12 months] |