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NCT05009472 Clinical Trial

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

Cleft Lip and Palate Clinical Trial

Official title:
Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Rapid Protocol and Face Mask Using CBCT

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05009472
Other study ID # ORTHO-109-2-E
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 26, 2021
Est. completion date July 2023

Study information
Verified date August 2021
Source Faculty of Dental Medicine for Girls
Contact taghreed alazzawi, master
Phone 00201001581382
Email TaghreedAlazzawi.p5821@azhar.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

maxillary expansion in cleft palate patient with expander and using face mask.

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 .

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date July 2023
Est. primary completion date July 2022
Accepts healthy volunteers No
Gender All
Age group 8 Years to 12 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• expander with deferential opening and petit face mask
bonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage

Locations
Country Name City State
Egypt Faculty of Dental Medicine for Girls Al-Azhar University Cairo Nasr City
Egypt Taghreddd Cairo

Sponsors (1)
Lead Sponsor Collaborator
Faculty of Dental Medicine for Girls

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes in 3 dimensions of skull before and after expansion Full skull Cone Beam Computerized Tomography Six months
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