Evaluation of DPA for Treatment of Upper Anterior Crowding | NCT06625658

Studies
Evaluation of DPA for Treatment of Upper Anterior Crowding

NCT06625658

Sponsor

Samia Omar

Status

Not yet recruiting

Last Update Posted

Feb 6, 2025Actual

Enrollment

9Estimated

Phase

Not Applicable

Conditions

Correction of Upper Crowding

Interventions

Direct printed clear aligners

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 2025

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

Jan 10, 2026Estimated

Primary Completion Date

Feb 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Sep 29, 2024

First Submission Date that Met QC Criteria

Oct 1, 2024

First Posted Date

Oct 3, 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

Feb 4, 2025

Last Update Posted Date

Feb 6, 2025Actual

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

Evaluation of effectiveness of direct printed clear aligner in relive crowding in maxillary incisor

Detailed Description

The present study will be performed to evaluate the effectiveness of direct 3D-printed aligners in the treatment of maxillary anterior teeth 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

9Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
clear aligner therapy	Experimental		Device: Direct printed clear aligners

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Direct printed clear aligners	Device	chang aligner every 10 days	clear aligner therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correction of Maxillary Anterior Teeth Crowding according to little irregularity index		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult paients .age 18-25y. patients with mild to moderate upper anterior crowding (1mm_6mm)
Healthy compliant and motivated patient. full dentition except wisdom teeth.

Exclusion Criteria:

Previous orthodontic treatments. Any systemic disease, pregnancy, or lactating females, with a pocket depth of more than 5mm.

Accepts Healthy Volunteers

Yes

Sex

All

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

Name	Role	Phone	Extension	Email
Samia O ali, candidate	Contact	00201032858606		samia.omar.dentistry@gmail.com

Overall Officials

Name	Affiliation	Role
Sara M .Hosny El kabbany, assistant professor	Study Principal Investigator Al azhar universty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al Azhar University		Cairo	Giza Governorate	76	Egypt

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