Slow Expansion and Protraction in Cleft Lip and Palate Patients

Not Applicable

• Conditions: Cleft Lip and Palate
• Interventions: Device: Maxillary Expander with Differential Opening (EDO); Device: Petit face mask

• Registration Number: NCT04997083
• Lead Sponsor: Faculty of Dental Medicine for Girls

Brief 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).

Study Timeline

• Study Start: 2021-07-15
• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Study First Posted: 2021-08-09
• Last Update Posted: 2021-08-09
• Primary Completion: 2022-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cleft lip and palate patients	Petit face mask	Cleft patients with transverse maxillary constriction and anteroposterior deficiency
cleft lip and palate patients	Maxillary Expander with Differential Opening (EDO)	Cleft patients with transverse maxillary constriction and anteroposterior deficiency

Primary Outcome Measures

Name	Time	Method
Changes in 3 dimensions of skull before and after expansion	Six months	Full skull Cone Beam Computerized Tomography

Trial Locations

Locations (1)

Faculty of dental medicine for girls, Al-Azhar University; 🇪🇬 Cairo, Nasr City, Egypt