Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient

Study Overview
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Brief Summary
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Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

Detailed Description
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Cleft lip and palate are among the most common deformities in children.Clefts patient are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty . Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth The upper jaw of patients with cleft palate will be expanded by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment by cone beam computed tomography (CBCT). .

Official Title
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Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Device: Maxillary Expander with Differential Opening (EDO)
* Device: Petit Face Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sexes. Cleft lip and palate patients. All patient age ranges from 8 to 12 years. All the cases showed maxillary arch constriction and deficiently All patients had maxillary permanent first molars. Primary lip adhesion and palatal closure. Exclusion Criteria: Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before. 2. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) . 3. Absent maxillary permanent first molars. 4. Uncooperative patients/parents

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cleft lip and palate patient<br>Clefts patient with transverse maxillary constriction and anteroposterior deficiency | Device: Maxillary Expander with Differential Opening (EDO)<br>* The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.<br>Device: Petit Face Mask<br>* The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. consist of forehead cap chin cap cross bar<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in 3D dimension of skull after and before expansion | Full skull Cone Beam Computerized Tomography | six month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alt-RAMEC, expansion, cleft lip and palate patient, cone beam computed tomography (CBCT), protraction, facemask, MAXILLARY EXPANDER WITH DIFFERENTIAL OPENING (EDO)