NCT04997083

Slow Expansion and Protraction in Cleft Lip and Palate Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Faculty of Dental Medicine for Girls · Other Government
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

• Cleft Lip and Palate

Interventions

Type	Name	Description
DEVICE	Maxillary Expander with Differential Opening (EDO)	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.
DEVICE	Petit face mask	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.

Timeline

• Start date: 2021-07-15
• Primary completion: 2022-07-01
• Completion: 2023-07-01
• First posted: 2021-08-09
• Last updated: 2021-08-09

Locations

1 site across 1 country: Egypt