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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04997083
Enrollment
10
Registered
2021-08-09
Start date
2021-07-15
Completion date
2023-07-31
Last updated
2021-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate

Keywords

Cleft lip and palate, Expansion, Slow expansion, Maxillary expander with differential opening (EDO), Protraction, Face mask, Cone beam computed tomography (CBCT)

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).

Interventions

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.

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.

Sponsors

Faculty of Dental Medicine for Girls
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in 3 dimensions of skull before and after expansionSix monthsFull skull Cone Beam Computerized Tomography

Countries

Egypt

Contacts

Primary ContactAmira H. Eldawy, Master
amiraeldawy.p5821@azhar.edu.eg+201112788674
Backup ContactTaghreed R. Alazzawi, Master
TaghreedAlazzawi.p5821@azhar.edu.eg+201001581382

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026