An interventional study of Rapid maxillary expansion and Leaf Self Expander in Three Dimensional, Dento-Skeletal and Leaf Self Expander, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to participants aged 3 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-02-03.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
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.
162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's enrollment of 20 is below the median of 30 across 114 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Other: Rapid maxillary expansion
Patients were treated with Leaf Self Expander for maxillary expansion.
Other: Leaf Self Expander
Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
Patients were treated with Leaf Self Expander for maxillary expansion.
Measurement of linear skeletal change
Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
Time frame: 6 months post-expansion
Measurement of angular skeletal change
Angular skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
Time frame: 6 months post-expansion
Measurement of linear dental change
Linear dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure.
Time frame: 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.
Time frame: 6 months post-expansion
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Al-Azhar University