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Slow Expansion and Protraction in Cleft Lip and Palate Patients

Primary Purpose

Cleft Lip and Palate

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Maxillary Expander with Differential Opening (EDO)
Petit face mask
Sponsored by
Faculty of Dental Medicine for Girls
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Cleft lip and palate, Expansion, Slow expansion, Maxillary expander with differential opening (EDO), Protraction, Face mask, Cone beam computed tomography (CBCT)

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Faculty of dental medicine for girls, Al-Azhar UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cleft lip and palate patients

Arm Description

Cleft patients with transverse maxillary constriction and anteroposterior deficiency

Outcomes

Primary Outcome Measures

Changes in 3 dimensions of skull before and after expansion
Full skull Cone Beam Computerized Tomography

Secondary Outcome Measures

Full Information

First Posted
August 4, 2021
Last Updated
August 4, 2021
Sponsor
Faculty of Dental Medicine for Girls
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1. Study Identification

Unique Protocol Identification Number
NCT04997083
Brief Title
Slow Expansion and Protraction in Cleft Lip and Palate Patients
Official Title
Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculty of Dental Medicine for Girls

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cleft lip and palate patients
Arm Type
Experimental
Arm Description
Cleft patients with transverse maxillary constriction and anteroposterior deficiency
Intervention Type
Device
Intervention Name(s)
Maxillary Expander with Differential Opening (EDO)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Petit face mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in 3 dimensions of skull before and after expansion
Description
Full skull Cone Beam Computerized Tomography
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira H. Eldawy, Master
Phone
+201112788674
Email
amiraeldawy.p5821@azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Taghreed R. Alazzawi, Master
Phone
+201001581382
Email
TaghreedAlazzawi.p5821@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amany M. Diab, PhD
Organizational Affiliation
Lecturer of Orthodontics Department, Faculty of Dental Medicine for Girls, Al-Azhar University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dental medicine for girls, Al-Azhar University
City
Cairo
State/Province
Nasr City
ZIP/Postal Code
0000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsena A. Abdelrazq, PhD
Phone
+201005839539
Email
MohsenaAhmad.el.8.383@azhar.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Evaluation of EDO, Slow maxillary expansion and facemask in patients with cleft lip and palate (CLP) using Cone Beam Computed Tomography (CBCT)
Citations:
PubMed Identifier
31901284
Citation
Alves ACM, Janson G, Mcnamara JA Jr, Lauris JRP, Garib DG. Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 Jan;157(1):7-18. doi: 10.1016/j.ajodo.2019.07.010.
Results Reference
background
PubMed Identifier
33580351
Citation
Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.
Results Reference
background
Links:
URL
https://link.springer.com/article/10.1007/s00784-021-03832-9
Description
Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial

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Slow Expansion and Protraction in Cleft Lip and Palate Patients

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