Tow Maxillary Hybrid Expanders Screw Supported Versus Lat... | NCT05193513

Studies
Tow Maxillary Hybrid Expanders Screw Supported Versus Lateral Angulated One; a Prospective Randomized Clinical Study

NCT05193513

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Jan 18, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Cross Bite

Interventions

hybrid expanders

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2021Actual

Primary Completion Date

Jun 10, 2023Estimated

Completion Date

Oct 14, 2023Estimated

First Submitted Date

Jan 3, 2022

First Submission Date that Met QC Criteria

Jan 3, 2022

First Posted Date

Jan 18, 2022Actual

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

Jan 3, 2022

Last Update Posted Date

Jan 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Abdallah EL sayed Mohamed Hassan, Comparison of tow maxillary hybrid expanders -perpendicular screw Supported versus lateral angulated one; a prospective randomized clinical study, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

in this study i will use to different designs of t maxillary hybrid expanders that consists of HYREX supported with tow miniscrews to treat the collapsed maxilla in Yonge adolescents

Detailed Description

the maxilla is expanded by tow diffrent designs of maxillary hybrid expanders

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group (1)	Experimental	tow perpendicular miniscrews supported hybrid expanders	Device: hybrid expanders
group (2)	Experimental	tow angulated miniscrews supported hybrid expanders	Device: hybrid expanders

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hybrid expanders	Device	tow maxillary hybrid expanders supported anteriorly with tow miniscrews	group (1) group (2)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in maxillary width	millimeter	12 weeks following end of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically free male or female patients
Patients that necessitated maxillary expansion due to constricted maxillary arch shown by a unilateral or bilateral posterior crossbite.
The patient should have no missing teeth except third molars.
Age ranged from 12 to 18 years old.
The patient should have a good gingival condition.
The patient should have a good periodontal condition.

Exclusion Criteria:

1-hisory of previous orthodontic treatment. 2- Lack of cooperation. 3- Mental problems. 4- Skeletal open bite. 5- TMJ problem.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al azhar university		Cairo		11311	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008310	Malocclusion

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided