Three Dimensional Evaluation of Dento-Skeletal Effects of Leaf Self Expander in Cleft Lip and Palate Patients (A Randomized Controlled Clinical Trail)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Measurement of linear skeletal change
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Months to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group A (Control group)
Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
Patients were treated with Leaf Self Expander for maxillary expansion.
Intervention: Rapid maxillary expansion (Other)
Group B (Tested group)
Patients were treated with Leaf Self Expander for maxillary expansion.
Intervention: Leaf Self Expander (Other)
Outcomes
Primary Outcomes
Measurement of linear skeletal change
Time Frame: 6 months post-expansion
Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure.
Secondary Outcomes
- Measurement of angular skeletal change(6 months post-expansion)
- Measurement of linear dental change(6 months post-expansion)
- Measurement of angular dental change(6 months post-expansion)
Investigators
Tasneem Ahmed Almohamady Khalil
Assistant lecturer, Orthodontic Department, Faculty of Oral and Dental Medicine, MUST University.
Al-Azhar University