Evaluation of Modified Hyrax Versus Quad Helix in Treatme... | NCT06300775

Studies
Evaluation of Modified Hyrax Versus Quad Helix in Treatment of Posterior Cross Bite

NCT06300775

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Mar 8, 2024Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Posterior Cross Bite

Interventions

modified hyrax
quad helix

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

Mar 2024

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 1, 2024Estimated

Primary Completion Date

May 1, 2025Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Oct 27, 2023

First Submission Date that Met QC Criteria

Mar 7, 2024

First Posted Date

Mar 8, 2024Actual

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

Mar 7, 2024

Last Update Posted Date

Mar 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Detailed Description

This study will be performed to evaluate the treatment of posterior cross-bite with modified hyrax & Quad helix appliances and to compare which one will provide better results in relation to chewing difficulty as a primary outcome of this study and also evaluate the increase in the inter maxillary width , sleep apnea and signs & symptoms of tempro-mandibular joints disorder in children with posterior cross- bite in mixed dentition Cases will be examined within a regular interval up to one year

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
Modified Hyrax	Active Comparator	Appliance used for rapid maxillary expansion	Device: modified hyrax
Quad Helix	Active Comparator	Appliance used for slow maxillary expansion	Device: quad helix

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modified hyrax	Device	Appliance used for rapid maxillary expansion	Modified Hyrax

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Chewing difficulty	the outcome will be measured by visual analogue scale	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with posterior cross-bite in mixed dentition stage.
Children with normal and mild growth pattern.
Children with completely erupted upper first molars.

Exclusion Criteria:

Children with advanced periodontal diseases.
Children having general diseases, syndromes.
Children with previous orthodontic.
Children with severe horizontal growth patterns.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sally mosallam, PH degree	Contact	01004288894		sally.mosallam@dentistry.cu.edu.eg.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo univeristry	Recruiting	Cairo			Egypt