Al-Azhar University
Cairo, 11651, Egypt
NCT Number: NCT07384338
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.
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Notify Me3 month–24 month
All sexes
Interventional
Not applicable
Cairo, 11651, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
Patients were treated with Leaf Self Expander for maxillary expansion.
Time frame: 6 months post-expansion
Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
Time frame: 6 months post-expansion
Angular skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
Time frame: 6 months post-expansion
Linear dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.
Time frame: 6 months post-expansion
Angular dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.
Al-Azhar University
Other
Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients (A Randomized Controlled Clinical Trail)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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