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

NCT05009472 | Unknown

• 1 other identifier: ORTHO-109-2-E
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cleft Lip and Palate

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Changes in 3 dimensions of skull before and after expansion

  Full skull Cone Beam Computerized Tomography

  Six months

Study Arms (1)

Cleft Lip and Palate Patient

EXPERIMENTAL

Cleft patient with transverse maxillary constriction and anteroposterior deficiency

Device: expander with deferential opening and petit face mask

Interventions

expander with deferential opening and petit face mask DEVICE

bonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage

Cleft Lip and Palate Patient

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ● 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty of Dental Medicine for Girls: lead

Study Sites (2)

Faculty of Dental Medicine for Girls Al-Azhar University

Cairo, Nasr City, 0000, Egypt

RECRUITING

Taghreddd

Cairo, Egypt

RECRUITING

Related Links

• Rapid maxillary expansion and face mask with class III malocclusion

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• dr. mohsena ahmad, phd

  Lecturer of orthodontics department Faculty of Dental Medicine for Girls Alazhar univercity

  STUDY DIRECTOR

Central Study Contacts

taghreed alazzawi, master

CONTACT

00201001581382; TaghreedAlazzawi.p5821@azhar.edu.eg

amira eldawy, master

CONTACT

00201112788674; amiraeldawy.p5821@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 17, 2021
• Study Start: June 26, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2023
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)