Trials / Completed
CompletedNCT07384338
Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients
Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients (A Randomized Controlled Clinical Trail)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Al-Azhar University · Academic / Other
- Sex
- All
- Age
- 3 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Rapid maxillary expansion | Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion. |
| OTHER | Leaf Self Expander | Patients were treated with Leaf Self Expander for maxillary expansion. |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
- First posted
- 2026-02-03
- Last updated
- 2026-02-03
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT07384338. Inclusion in this directory is not an endorsement.