3D Evaluation of Clear Aligners Versus Fixed Orthodontic... | NCT06510569

Studies
3D Evaluation of Clear Aligners Versus Fixed Orthodontic Treatment of Lower Anterior Crowding

NCT06510569

Sponsor

Haidy Fekry

Status

Completed

Last Update Posted

Jul 19, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Pathological Resorption of External Root

Interventions

U lab aligners
oramco bracket

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2022Actual

Primary Completion Date

Apr 10, 2024Actual

Completion Date

Jun 1, 2024Actual

First Submitted Date

Jun 20, 2024

First Submission Date that Met QC Criteria

Jul 14, 2024

First Posted Date

Jul 19, 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

Jul 14, 2024

Last Update Posted Date

Jul 19, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate and compare clear aligners versus fixed orthodontic treatment of lower anterior crowding with the use of cone-beam computed tomography within maximum 6 months or until correction of lower anterior crowding whichever is nearest to occur.

Detailed Description

Group (A): Patients will be treated with conventional fixed orthodontic treatment in lower anterior crowding.

Group (B): Patients will be treated with clear aligner therapy in lower anterior crowding.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clear aligner therapy	Experimental	U lab aligners	Device: U lab aligners
Fixed orthodontic treatment	Experimental	Oromo bracket	Device: oramco bracket

Interventions

Name	Type	Description	Arm Group Labels	Other Names
U lab aligners	Device	Aligner group change the aligner every 10 days	Clear aligner therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correction of lower anterior crowding	according to little irregularity index	6 months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Root resorption	CBCT evaluation of root resorption	6 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult female patients . age 18-25 y . Patients with mild to moderate lower anterior crowding (1 mm - 6 mm ) . Healthy compliant and motivated patient . full dentition except wisdom teeth .

Exclusion Criteria:

Previous orthodontic treatments. Any systemic disease Pregnant and lactating female. pocket depth more than 5 mm.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

25 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
samir A ibrahim, proffesor	Al azhar universty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al Azhar Universty		Cairo		002	Egypt
Haidy Fekry

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36437397	Result	Fiori A, Minervini G, Nucci L, d'Apuzzo F, Perillo L, Grassia V. Predictability of crowding resolution in clear aligner treatment. Prog Orthod. 2022 Nov 28;23(1):43. doi: 10.1186/s40510-022-00438-z.