Effects of Clear Aligners Versus Fixed Appliances on Occl... | NCT05737290

Studies
Effects of Clear Aligners Versus Fixed Appliances on Occlusion After Treatment of Mild Anterior Crowding

NCT05737290

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

May 13, 2026Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Occlusion

Interventions

Clear aligners
Fixed appliances

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

May 2026

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

May 1, 2024Actual

Primary Completion Date

Mar 1, 2026Actual

Completion Date

Apr 1, 2026Actual

First Submitted Date

Feb 6, 2023

First Submission Date that Met QC Criteria

Feb 20, 2023

First Posted Date

Feb 21, 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

May 9, 2026

Last Update Posted Date

May 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this study is to evaluate effects of clear aligners versus fixed appliances on occlusion after treatment of mild anterior crowding a T-scan study.

Detailed Description

Intervention:

Group 1. Patients treated with clear aligner. Patients with mild anterior crowding will be treated with non-extraction treatment using clear aligners.

Group 2. Patients treated with fixed appliance. Patients with mild anterior crowding will be treated with non-extraction treatment using fixed appliances.

Observations:

Multi-bite closure in centric occlusion using T-Scan® recordings were obtained before and after treatment from each subject to measure the occlusal parameters to be analyzed during this study.

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

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Active Comparator		Device: Clear aligners
Group B	Active Comparator		Device: Fixed appliances

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clear aligners	Device	Patients with mild anterior crowding will be treated with non-extraction treatment using clear aligners.	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distribution of occlusal forces	Amount of magnitude of occlusal forces after treatment by clear aligners	1 Year and 6 Months
Distribution of occlusal forces	Amount of magnitude of occlusal forces after treatment by fixed appliances	1 Year and 6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between the age (14-22 years).
Fully erupted permanent dentition, 3rd molars excluded.
Healthy, compliant, and motivated patients who can visit the department regularly.
Non-extraction treatment.
Class I with mild anterior crowding lower and/ or upper.
Good oral and general health.

Exclusion Criteria:

Previous orthodontic treatment.
Craniofacial abnormalities, congenital syndromes of the craniofacial area.
Anterior or posterior crossbite.
Anterior or lateral open bite.
Poor oral hygiene or periodontally compromised patient.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

22 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Moaz Hafez Abdelrhman, Master	Al-Azhar University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al Azhar University		Cairo	Nasr City	11765	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27468595	Background	Weir T. Invisalign treatment of lower incisor extraction cases. Aust Orthod J. 2016 May;32(1):82-7.

ID	Term
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries

ID	Term
D009967	Orthodontic Appliances
D009970	Orthodontics
D003813	Dentistry