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 2021-08-09.
Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment
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).
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.
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Exclusion Criteria:
Cleft patients 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. It consists of forehead cap, chin cap, and cross bar.
Changes in 3 dimensions of skull before and after expansion
Full skull Cone Beam Computerized Tomography
Time frame: Six months
Plan to share: No — Evaluation of EDO, Slow maxillary expansion and facemask in patients with cleft lip and palate (CLP) using Cone Beam Computed Tomography (CBCT)
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Faculty of Dental Medicine for Girls