Cleft Lip, Cleft Palate, Dento-Skeletal, Leaf Self Expander, Three Dimensional
Conditions
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.
Interventions
Patients were treated with conventional therapy with rapid maxillary expansion (RME) for maxillary expansion.
OTHERLeaf Self Expander
Patients were treated with Leaf Self Expander for maxillary expansion.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 24 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of linear skeletal change | 6 months post-expansion | Linear skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of angular skeletal change | 6 months post-expansion | Angular skeletal change was assessed to evaluate change in skeletal dimensions following the expansion procedure. |
| Measurement of linear dental change | 6 months post-expansion | Linear dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure. |
| Measurement of angular dental change | 6 months post-expansion | Angular dental change was assessed to evaluate change in tooth position and arch dimensions following the expansion procedure. |
Countries
Egypt
Outcome results
None listed