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Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients

Primary Purpose

Cleft Lip and Palate

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
expander with deferential opening and 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 palate patient, Rapid maxillary expansion RME, cone beam computed tomography CBCT, expansion, face mask

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ● Patients of both sexes.

    • Cleft lip and palate patients.
    • All patient age range 8-12 years.
    • All the case showed maxillary arch constriction and deficiency.
    • All patients had maxillary permanent first molars.
    • Primary lip adhesion and palatal closure.

Exclusion Criteria:

  • • Absent maxillary permanent first molars.

    • Patients had received any surgical assisted rapid maxillary expansion, maxillary protraction or fixed orthodontics before.
    • Less than two dental unit beside maxillary first molar.
    • Uncooperative patients/parents.

Sites / Locations

  • Faculty of Dental Medicine for Girls Al-Azhar UniversityRecruiting
  • TaghredddRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cleft Lip and Palate Patient

Arm Description

Cleft patient 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
July 29, 2021
Last Updated
August 11, 2021
Sponsor
Faculty of Dental Medicine for Girls
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1. Study Identification

Unique Protocol Identification Number
NCT05009472
Brief Title
Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients
Official Title
Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Rapid Protocol and Face Mask Using CBCT
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 26, 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
maxillary expansion in cleft palate patient with expander and using face mask.
Detailed Description
patient with cleft palate and maxillary constriction, deficiency will be treat using expander with differential opening which has two screws on anteriorly and another posteriorly positional in midline palate anteriorly as much as possible. rapid maxillary expansion will be using one turns in day(two turns in the morning and two turns in the evening). with petit face mask for maxillary protraction and superimposition CBCT will be taken between before and after treatment .

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 palate patient, Rapid maxillary expansion RME, cone beam computed tomography CBCT, expansion, face mask

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 Patient
Arm Type
Experimental
Arm Description
Cleft patient with transverse maxillary constriction and anteroposterior deficiency
Intervention Type
Device
Intervention Name(s)
expander with deferential opening and petit face mask
Intervention Description
bonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage
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
No
Eligibility Criteria
Inclusion Criteria: ● Patients of both sexes. Cleft lip and palate patients. All patient age range 8-12 years. All the case showed maxillary arch constriction and deficiency. All patients had maxillary permanent first molars. Primary lip adhesion and palatal closure. Exclusion Criteria: • Absent maxillary permanent first molars. Patients had received any surgical assisted rapid maxillary expansion, maxillary protraction or fixed orthodontics before. Less than two dental unit beside maxillary first molar. Uncooperative patients/parents.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
taghreed alazzawi, master
Phone
00201001581382
Email
TaghreedAlazzawi.p5821@azhar.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
amira eldawy, master
Phone
00201112788674
Email
amiraeldawy.p5821@azhar.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dr. mohsena ahmad, phd
Organizational Affiliation
Lecturer of orthodontics department Faculty of Dental Medicine for Girls Alazhar univercity
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
taghreed alazzawi, master
Phone
00201001581382
Email
taghreedalazzawi.p5821@azhar.edu.eg
First Name & Middle Initial & Last Name & Degree
amira eldawr, master
Phone
00201112788674
Email
amiraeldawy.p5821@azhar.edu.eg
Facility Name
Taghreddd
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
taghreed alazzawi, master
Phone
00201001581382
Email
TaghreedAlazzawi.p5821@azhar.edu.eg
First Name & Middle Initial & Last Name & Degree
amira eldawy, master
Phone
00201112788674
Email
amiraeldawy.p5821@azhar.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
treatment cleft lip and palate patient with EDO with rapid protocol and face mask
Links:
URL
http://doi.org/10.2319/092913-707.1
Description
Rapid maxillary expansion and face mask with class III malocclusion

Learn more about this trial

Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients

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