Slow Expansion and Protraction in Cleft Lip and Palate Patients

Study Overview
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Brief Summary
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Evaluate the treatment outcome of slow maxillary expansion 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. Cleft patients 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 using maxillary Expander with Differential Opening (EDO) which has two screws; one anterior and one posterior. This will be done with slow expansion protocol, which is one 1/4 turn three times weekly. Petit facemask will be used to protract the retracted maxilla. The differences in measurements between before and after treatment will be assessed by cone beam computed tomography (CBCT).

Official Title
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Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask

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: All patient age ranges from 8 to 12 years. Patients of both sexes. Cleft lip and palate patients. All the cases showed maxillary arch constriction and deficiency. All patients had maxillary permanent first molars. Primary lip adhesion and palatal closure. Exclusion Criteria: Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before. Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar). Absent maxillary permanent first molars. 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 patients<br>Cleft patients 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. It consists of forehead cap, chin cap, and cross bar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 3 dimensions of skull before and after expansion | Full skull Cone Beam Computerized Tomography | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cleft lip and palate, Expansion, Slow expansion, Maxillary expander with differential opening (EDO), Protraction, Face mask, Cone beam computed tomography (CBCT)