Rapid Maxillary Expansion and Protraction by Expander Dif... | NCT05009472

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

NCT05009472

Sponsor

Faculty of Dental Medicine for Girls

Status

Unknown status

Last Update Posted

Aug 17, 2021Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Cleft Lip and Palate

Interventions

expander with deferential opening and petit face mask

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2021Actual

Primary Completion Date

Jul 2022Estimated

Completion Date

Jul 2023Estimated

First Submitted Date

Jul 29, 2021

First Submission Date that Met QC Criteria

Aug 11, 2021

First Posted Date

Aug 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2021

Last Update Posted Date

Aug 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Taghreed riyadh saleh alazzawi, principal investigator, Faculty of Dental Medicine for GirlsPrincipal Investigator

Lead Sponsor

Faculty of Dental Medicine for GirlsOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in 3 dimensions of skull before and after expansion	Full skull Cone Beam Computerized Tomography	Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
taghreed alazzawi, master	Contact	00201001581382		TaghreedAlazzawi.p5821@azhar.edu.eg
amira eldawy, master	Contact	00201112788674		amiraeldawy.p5821@azhar.edu.eg

Overall Officials

Name	Affiliation	Role
dr. mohsena ahmad, phd	Lecturer of orthodontics department Faculty of Dental Medicine for Girls Alazhar univercity	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dental Medicine for Girls Al-Azhar University	Recruiting	Cairo	Nasr City	0000	Egypt

References Module

Citations

Not provided

ID	Term
D008047	Lip Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D009056	Mouth Abnormalities