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Design: Two-arm parallel randomized clinical trial in mixed dentition (6-12 years).
Arms: (1) 9 mm, 900 g leaf expander; (2) 9 mm Hyrax expander. Follow-up: From appliance insertion → completion of intended expansion → 6-month retention.
Primary outcome: Pain perception during the first 7 days post-insertion (daily patient-reported scale).
Secondary outcomes: Skeletal and dental changes on CBCT.
Participants receive a banded maxillary expansion appliance cemented to maxillary first permanent molars, assigned to:
Leaf expander arm: Nickel-titanium leaf-spring expander, 9 mm screw, delivering force of ~900 g.
Hyrax expander arm: Conventional tooth-borne jackscrew expander, 9 mm screw. Standard activation: two turns per week.
Retention: Both appliances kept passively in situ for 6 months of retention following achievement of planned expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Banded Leaf expander supported on the maxillary first permanent molars | Experimental | 9mm leaf expander delievering 900 gm force will be supported on the upper first permanent molars with the appliance arm extending to the canines |
|
| Banded Hyrax expander supported on the maxillary first permanent molars | Active Comparator | 9mm Hyrax expander will be supported on the upper first permanent molars with the appliance arm extending to the canines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Leaf expander | Device | The Leaf expander incorporates Nickel Titanium springs that will not require the patients' home activation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain perception | Pain perception during the first week after insertion using Wong-Becker faces scale with minimum value of zero and maximum value of ten, ten score represents the worst pain percieved. | first week after appliance insertion |
| Measure | Description | Time Frame |
|---|---|---|
| skeletal expansion | skeletal expansion using Cone Beam Computed Tomography skeletal expansion: linear distances of the midpalatal suture opening measured in mm between the pre- and post-axial cuts of the CBCT | 6 months post expansion |
| dental tipping |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D063173 | Retrognathia |
| ID | Term |
|---|---|
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
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statistician
| Hyrax expander | Device | Hyrax expander incorporates a screw that requires the patients' home activation |
|
Angular measurement of upper first molars angulation measured in degrees between pre- and post-coronal cuts of the CBCT
| 6 months post-expansion |
| digital models parameters | Intermolar width, intercanine width | six months post-expansion |
| 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 |