En Masse Distaliaztion Via Skeletal Anchorage | NCT05245929

Studies
En Masse Distaliaztion Via Skeletal Anchorage

NCT05245929

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Feb 18, 2022Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Orthodontic Appliance Complication, Angle Class II Patients, Distalization

Interventions

Distalization

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

Feb 2022

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

Jan 5, 2021Actual

Primary Completion Date

May 2023Estimated

Completion Date

Jan 2024Estimated

First Submitted Date

Feb 9, 2022

First Submission Date that Met QC Criteria

Feb 9, 2022

First Posted Date

Feb 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

Feb 9, 2022

Last Update Posted Date

Feb 18, 2022Actual

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.

Detailed Description

Not provided

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

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Skeletally anchored Distal Jet appliance	Active Comparator		Device: Distalization
Skeletally anchored Hyrax screw distalizer	Active Comparator		Device: Distalization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Distalization	Device	Distalizing the posterior maxillary segment	Skeletally anchored Distal Jet appliance Skeletally anchored Hyrax screw distalizer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amount of distalization	difference in initial and final position of maxillary posterior segment	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Full set of permanent teeth present, except for third molar
Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
No systemic conditions interfering with treatment, as reported by patient
No previous Orthodontic treatment
Good Oral Hygiene
No use of any for of anti-inflammatory drugs

Exclusion Criteria:

Patient who required surgery to correct skeletal discrepancies
Patient with congenital dentoskeletal disorders
Missed or Mutilated teeth in Maxillary arch
Patients with poor oral hygiene

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

16 Years

Standard Ages

Child

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, faculty of dental medicine orthodontic clinic	Recruiting	Cairo	Nasr City		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