Evaluation of Root Parallelism in Cases of Anterior Teeth... | NCT06803940

Studies
Evaluation of Root Parallelism in Cases of Anterior Teeth Spacing Clear Aligner Versus Fixed Appliances

NCT06803940

Sponsor

Faculty of Dental Medicine for Girls

Status

Completed

Last Update Posted

Jan 31, 2025Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

The Present Study Aimed to Evaluate Root Parallelism in Cases of Anterior Teeth Spacing Treated With Clear Aligner Versus Fixed Orthodontic Appliances
Spacing Between Anterior Teeth

Interventions

clear aligner
orthodontic treatment

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

Status Module

Record Verification Date

Jan 2025

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 1, 2023Actual

Primary Completion Date

Oct 15, 2024Actual

Completion Date

Nov 1, 2024Actual

First Submitted Date

Jan 5, 2025

First Submission Date that Met QC Criteria

Jan 28, 2025

First Posted Date

Jan 31, 2025Actual

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

Jan 28, 2025

Last Update Posted Date

Jan 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amira Osama Elshall, Master's student, Faculty of Dental Medicine for GirlsPrincipal Investigator

Lead Sponsor

Faculty of Dental Medicine for GirlsOTHER_GOV

Collaborators

Not provided

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 root parallelism in cases of anterior teeth spacing treated with clear aligner versus fixed orthodontic appliances

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
aligner	Experimental	intervention patient treated with clear aligner therapy	Procedure: clear aligner
fixed appliance	Active Comparator	patient treated with conventional appliance	Procedure: orthodontic treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
clear aligner	Procedure	closing of spacing in anterior teeth with clear aligner therapy	aligner

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
root parallelism	root angulation	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: 1. Patients with anterior spacing as less than 2mm for anterior 2. Age range from 14 to 22 years old with no sex discrimination. 3. Good oral hygiene. 4. Presence of all permanent teeth not including third molars. 5. Provide informed consent and willingness to cooperate with study protocol.

Exclusion Criteria:

Medical problems or craniofacial disorders known to affect bone remodeling.
Congenital defect or deformed anterior teeth.
Presence of chronic or acute periodontal disease.
Radiographic evidence of bone loss.
History of systemic disease.
Previous orthodontic treatment.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

20 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
Faculty of Dental Medicine		Cairo	Naser City	11788	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

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D009968	Orthodontic Appliances, Removable
D009970	Orthodontics

ID	Term
D009967	Orthodontic Appliances
D003813	Dentistry