Slow Expansion and Protraction in Cleft Lip and Palate Patients

Faculty of Dental Medicine for Girls10 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cleft Lip and Palate

Interventions

Maxillary Expander with Differential Opening (EDO)DEVICE

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.

Petit face maskDEVICE

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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of dental medicine for girls, Al-Azhar University

Cairo, Nasr City, Egypt

RECRUITING

Outcomes

Primary Outcomes

Changes in 3 dimensions of skull before and after expansion

Full skull Cone Beam Computerized Tomography

Time frame: Six months

Central Contacts

Amira H. Eldawy, Master

CONTACT

+201112788674 amiraeldawy.p5821@azhar.edu.eg

Taghreed R. Alazzawi, Master

CONTACT

+201001581382 TaghreedAlazzawi.p5821@azhar.edu.eg

Data from ClinicalTrials.gov

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