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Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).
Cleft lip and palate are among the most common deformities in children. Cleft patients are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty. Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth. The upper jaw of patients with cleft palate will be expanded using maxillary Expander with Differential Opening (EDO) which has two screws; one anterior and one posterior. This will be done with slow expansion protocol, which is one 1/4 turn three times weekly. Petit facemask will be used to protract the retracted maxilla. The differences in measurements between before and after treatment will be assessed by cone beam computed tomography (CBCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cleft lip and palate patients | Experimental | Cleft patients with transverse maxillary constriction and anteroposterior deficiency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maxillary Expander with Differential Opening (EDO) | Device | The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 3 dimensions of skull before and after expansion | Full skull Cone Beam Computerized Tomography | Six months |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amira H. Eldawy, Master | Contact | +201112788674 | amiraeldawy.p5821@azhar.edu.eg | |
| Taghreed R. Alazzawi, Master | Contact | +201001581382 | TaghreedAlazzawi.p5821@azhar.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amany M. Diab, PhD | Lecturer of Orthodontics Department, Faculty of Dental Medicine for Girls, Al-Azhar University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dental medicine for girls, Al-Azhar University | Recruiting | Cairo | Nasr City | 0000 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31901284 | Background | Alves ACM, Janson G, Mcnamara JA Jr, Lauris JRP, Garib DG. Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 Jan;157(1):7-18. doi: 10.1016/j.ajodo.2019.07.010. | |
| 33580351 | Background | Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12. |
| Label | URL |
|---|---|
| Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial | View source |
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Evaluation of EDO, Slow maxillary expansion and facemask in patients with cleft lip and palate (CLP) using Cone Beam Computed Tomography (CBCT)
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| Petit face mask | Device | The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar. |
|
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |