An interventional study of Maxillary Expander with Differential Opening (EDO) and Petit Face Mask in Cleft Lip and Palate, sponsored by Faculty of Dental Medicine for Girls. Status unknown at 1 site in Egypt. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment
Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC 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.Clefts patient 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 by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment by cone beam computed tomography (CBCT). .
162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 10 is below the median of 30 across 114 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Faculty of Dental Medicine for Girls is the lead sponsor of 52 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.
Clefts patient with transverse maxillary constriction and anteroposterior deficiency
Device: Maxillary Expander with Differential Opening (EDO) · Device: Petit Face Mask
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.
The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. consist of forehead cap chin cap cross bar
change in 3D dimension of skull after and before expansion
Full skull Cone Beam Computerized Tomography
Time frame: six month
Plan to share: No — Evaluation of EDO ,Alt-RAMEC With Facemask in Patients With Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Faculty of Dental Medicine for Girls