En-mass Retraction by KILBON Versus CAT Appliances | NCT06366737

Studies
En-mass Retraction by KILBON Versus CAT Appliances

NCT06366737

Sponsor

Cairo University

Status

Not yet recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Maxillary Prognathism

Interventions

KILBON Appliance
CAT appliance

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

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2024Estimated

Primary Completion Date

Jun 2025Estimated

Completion Date

Aug 2025Estimated

First Submitted Date

Mar 28, 2024

First Submission Date that Met QC Criteria

Apr 10, 2024

First Posted Date

Apr 16, 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

Sep 16, 2024

Last Update Posted Date

Sep 19, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

en-mass retraction by lingual retractor versus clear alighner therapy

Detailed Description

Comparative Effectiveness Of Lingual Retractor Versus Clear Aligner Appliances In Adult Patients With Maxillary Dentoalveolar Protrusion Treated By Upper First Premolars Extraction And Enmass Retraction Of Maxillary Anterior Teeth Segment Using Palatal Orthodontic Miniscrews :A Randomized Clinical Trial

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
KILBON appliance	Active Comparator	en-mass retraction by lingual retractor	Device: KILBON Appliance
CAT appliance	Active Comparator	en-mass retraction by clear aligner	Device: CAT appliance

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KILBON Appliance	Device	palatal TAD assissted lingual appliance for en-mass retraction	KILBON appliance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient satisfaction during & after phase I treatment.	questionnaire	6 months

Secondary Outcomes

Measure	Description	Time Frame
inclination of upper anterior teeth	angle measurement of long axis of maxillary central to maxillary plane in degrees	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients with maxillary dentoalveolar protrusion with mild crowding

Exclusion Criteria:

- adult patients with maxillary dentoalveolar protrusion with moderate to severe crowding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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
Faculty of Dentistry		Cairo			Egypt	zainab abdulrhman

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