Poul Gjessing Versus T Loops for Orthodontic Maxillary Ca... | NCT05727124

Studies
Poul Gjessing Versus T Loops for Orthodontic Maxillary Canine Retraction

NCT05727124

Sponsor

Al-Azhar University

Status

Unknown status

Last Update Posted

Feb 14, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Canine Retraction

Interventions

Poul Gjessing
T loops

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

Aug 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

Aug 1, 2022Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Feb 1, 2025Estimated

First Submitted Date

Feb 6, 2023

First Submission Date that Met QC Criteria

Feb 13, 2023

First Posted Date

Feb 14, 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

Feb 13, 2023

Last Update Posted Date

Feb 14, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Saleh Abdullah Mohammed Abdulsalam, BDS(2018) ,Faculty of dentistry, Aden university, Yemen, 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

Poul Gjessing versus T loops for orthodontic maxillary canine

Detailed Description

Split mouth study one side using Poul Gjessing spring and other side using T loops

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
Evaluation of Poul Gjessing spring for orthodontic maxillary canine retraction	Active Comparator	20 Orthodontic patient treated by Poul Gjessing spring for canine retraction split mouth.	Device: Poul Gjessing
Evaluation of T loop for orthodontic maxillary canine retraction	Active Comparator	20 Orthodontic patient treated by T loop for canine retraction split mouth	Device: T loops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Poul Gjessing	Device	maxillary canine retraction	Evaluation of Poul Gjessing spring for orthodontic maxillary canine retraction

Measure	Description	Time Frame
rate of canine retraction distance		six months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Class I or II div 1, orthodontic patients, with moderate to severe crowding who are indicated for maxillary first premolar extraction. 2- All permanent teeth are erupted (3rd molars are not included). 3- Good oral and general health. 4- No previous orthodontic treatment.

Exclusion Criteria:

- 1- Orthodontic cases that could be treated with no indication for extraction therapy.

2- Orthodontic cases that are indicate for the extraction of any tooth other than maxillary first premolars. 3- Patients with systemic diseases that might interfere with the of orthodontic tooth movement.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

25 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
Alazhar university		Cairo		99988	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