Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients

Al-Azhar University

Status: Completed

Conditions: Dento-Skeletal; Cleft Palate; Cleft Lip; Leaf Self Expander; Three Dimensional

Treatments: Other: Rapid maxillary expansion; Other: Leaf Self Expander

Study type: Interventional

Funder types: Other

Identifiers

NCT07384338

P-OR-23-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 3 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with unilateral or bilateral cleft lip and palate in mixed dentition.
• Lip and palate repair was performed from 3 to 24 months of age.
• Presence of maxillary constriction and need of maxillary expansion prior to secondary alveolar bone grafting.
• Good periodontal health.

Exclusion criteria

• Previous orthodontic treatments.
• Any systemic diseases.
• Multiple carious lesions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A (Control group)

Active Comparator group

Description:

Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion. Patients were treated with Leaf Self Expander for maxillary expansion.

Treatment:

Other: Rapid maxillary expansion

Group B (Tested group)

Experimental group

Description:

Patients were treated with Leaf Self Expander for maxillary expansion.

Treatment:

Other: Leaf Self Expander