Dentoskeletal Changes Expansion Using Invisalign Versus C... | NCT05899530

Studies
Dentoskeletal Changes Expansion Using Invisalign Versus Conventional Expander

NCT05899530

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Jun 13, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Expansion of Maxillary Arch
Maxillary Hypoplasia

Interventions

Invisalign
Conventional expander

Countries

Not provided

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

ID	Type	Description
S.A.Saleh	Registry Identifier	Saleh Anwar Saleh
M.A.Salem	Registry Identifier	Mohamed Ahmad Salem
M.A.Abdarrazik	Registry Identifier	Mohsena Ahmad Abdarrazik

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 22, 2023Estimated

Primary Completion Date

Mar 30, 2024Estimated

Completion Date

May 31, 2024Estimated

First Submitted Date

May 25, 2023

First Submission Date that Met QC Criteria

Jun 9, 2023

First Posted Date

Jun 12, 2023Actual

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

Jun 11, 2023

Last Update Posted Date

Jun 13, 2023Actual

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

Cbct evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander

Detailed Description

Using cbct for evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander hyrax

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional expander	Active Comparator	Expansion using conventional orthodontic expander(hyrax)	Device: Conventional expander
Invisalign	Experimental	Expansion with Invisalign appliance	Device: Invisalign

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Invisalign	Device	Expansion using Invisalign versus conventional expander	Invisalign

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Linear amount of midpalatal Suture opening	Apperance of Distema , calculate the amount of general space	4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age (12-16)
Good oral hygiene
Constricted maxilla or moderate crowding

Exclusion Criteria:

Patient receive drugs
Periodontal diseas
Past Orthodontic treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amro S Ibrahim	Contact	+201002125687		amrIbrahim.209@azhar.edu.eg
Mohsena A Abdarrazik	Contact	+201005839539		mohsenaahmad.el.8.383@azhar.edu.eg

Overall Officials

Name	Affiliation	Role
Saleh A Saleh, Professor	Al-Azhar University	Study Director
Mohamad A Salem, Professor	Al-Azhar University	Study Director
Mohsena A Abdarrazik, Lecturer

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D063173	Retrognathia

Ancestor Terms

ID	Term
D007569	Jaw Abnormalities
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases
D019767	Maxillofacial Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009968	Orthodontic Appliances, Removable

Ancestor Terms

ID	Term
D009967	Orthodontic Appliances
D009970	Orthodontics
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided