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This study aims to evaluate the dento-alveolar changes after maxillary expansion in cleft lip and palate patients by Leaf Self Expander, as compared to conventional Rapid Maxillary Expander using digital cast analysis and three-dimensional cone-beam computed tomography.
Orofacial clefts are the most prevalent among congenital malformations, which can involve the upper lip, alveolar ridge or/and the palate and, in general, cause esthetic, functional, and psychosocial impairments in different magnitudes, depending on its location and extension.
The Leaf Self Expander (LSE) is a new technology that similar to LE in design except absence of the reactivation screw and respects the principle of producing predetermined light, constant forces, without any intervention by the patient, parents or orthodontist. Where it is composed of three leaf springs compressed by the laboratory before delivery, it is deactivated spontaneously until the programmed expansion is achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Control group) | Active Comparator | Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion. Patients were treated with Leaf Self Expander for maxillary expansion. |
|
| Group B (Tested group) | Experimental | Patients were treated with Leaf Self Expander for maxillary expansion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid maxillary expansion | Other | Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of linear skeletal change | Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure. | 6 months post-expansion |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of angular skeletal change | Angular skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure. | 6 months post-expansion |
| Measurement of linear dental change |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University | Cairo | 11651 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| Leaf Self Expander | Other | Patients were treated with Leaf Self Expander for maxillary expansion. |
|
Linear dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.
| 6 months post-expansion |
| Measurement of angular dental change | Angular dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure. | 6 months post-expansion |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |