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Clinical Trials/NCT04970095
NCT04970095
Unknown
Not Applicable

Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)

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
change in 3D dimension of skull after and before expansion
Last Updated
4 years ago

Overview

Brief Summary

Evaluate the treatment outcome of Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC 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.Clefts patient 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 by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment 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

sarah salah khalil Abdelaal

Principal Investigator

Faculty of Dental Medicine for Girls

Eligibility Criteria

Inclusion Criteria

  • Patients of both sexes.
  • Cleft lip and palate patients.
  • All patient age ranges from 8 to 12 years.
  • All the cases showed maxillary arch constriction and deficiently
  • All patients had maxillary permanent first molars.
  • Primary lip adhesion and palatal closure.

Exclusion Criteria

  • Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.
  • Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .
  • Absent maxillary permanent first molars.
  • Uncooperative patients/parents

Outcomes

Primary Outcomes

change in 3D dimension of skull after and before expansion

Time Frame: six month

Full skull Cone Beam Computerized Tomography

Study Sites (1)

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