Slow Expansion and Protraction in Cleft Lip and Palate Patients

Faculty of Dental Medicine for Girls

Status: Unknown

Conditions: Cleft Lip and Palate

Treatments: Device: Petit face mask; Device: Maxillary Expander with Differential Opening (EDO)

Study type: Interventional

Funder types: Other

Identifiers

NCT04997083

ORTHO-109-2-D

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

cleft lip and palate patients

Experimental group

Description:

Cleft patients with transverse maxillary constriction and anteroposterior deficiency

Treatment:

Device: Maxillary Expander with Differential Opening (EDO)

Device: Petit face mask