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Clinical Trials/NCT04997083
NCT04997083
Unknown
Not Applicable

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

Faculty of Dental Medicine for Girls1 site in 1 country10 target enrollmentJuly 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Lip and Palate
Sponsor
Faculty of Dental Medicine for Girls
Enrollment
10
Locations
1
Primary Endpoint
Changes in 3 dimensions of skull before and after expansion
Last Updated
4 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 15, 2021
End Date
July 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Faculty of Dental Medicine for Girls
Responsible Party
Principal Investigator
Principal Investigator

Amira Helmy Abdulsattar Eldawy

Principal Investigator

Faculty of Dental Medicine for Girls

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Changes in 3 dimensions of skull before and after expansion

Time Frame: Six months

Full skull Cone Beam Computerized Tomography

Study Sites (1)

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