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CompletedNCT07745855LIIUpdated Aug 5, 2026

The Reliability and Validity of Little's Irregularity Index Assessment

An observational study in Dental Crowding and Malocclusion, Angle Class I, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to female participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
20
Ages
13 Years to 18 Years
Sex
Female
01

Study summary

The primary aim of the current study was to estimate the validity, reliability, and repeatability of LII measurements

Read the detailed description

the primary aim of the current study was to estimate the validity, reliability, and repeatability of LII measurements made directly on digital models compared to those made on traditional plaster models. As a secondary aim, the same comparisons will also performed between digital photographs of study models and their corresponding plaster models.

02

Conditions studied

  • Dental Crowding
  • Malocclusion, Angle Class I

Keywords

  • Little's Irregularity Index
03

In context

Crowding

88 studies on the registry are indexed under Crowding; 22 are open to participants now.

This study's enrollment of 20 is below the median of 664 across 14 observational studies indexed under Crowding.

Browse Crowding studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study models with their corresponding direct digital intra-oral models and photos are obtained from Egyptian females patients from Cairo_Patients are medical free from systemic disease with age range 13-18 years suffering from mild to moderate anterior teeth crowding with class I malocclusion

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Standardized study models for patients with a full set of permanent teeth (the third molars are not considered).
  • All study models for patients with Angle class I malocclusion.
  • All study models for patients with mild to moderate anterior teeth crowding in both arches
  • Corresponding standardized direct scanned intraoral digital models for all selected study models
  • Corresponding standardized digital photos for all selected study models
  • Corresponding standardized digital intra-oral photos for all selected study models

Exclusion criteria

Exclusion criteria:

  • Damaged or distorted study models
  • Unclear or distorted digital models (STL file)
  • Unclear or distorted digital photos of study models (JPG File)
  • Unclear or distorted intra-oral photos (JPG File)
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
20 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. validity, reliability, and repeatability of Little's Irregularity Index measurements

    the primary aim of the current study was to estimate the validity, reliability, and repeatability of LII measurements made directly on digital models compared to those made on traditional plaster models

    Time frame: 3 months

07

Study locations

1 site
  • Faculty of Dentistry
    Cairo, Nasr City 11884, Egypt
08

References and documents

Publications

  • The effects of the twin arch bracket system in class 1 orthodontic patients for a control of orthodontic tooth movement: A randomized controlled clinical trial

Individual participant data

Plan to share: Yes — After complection of the current study

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07745855
Responsible party
Mohammed B.M. Farhat (Master degree graduate student in orthodontic department, Al-Azhar University) — Principal investigator
First posted
Aug 4, 2026
Start date
Jun 1, 2021
Primary completion
Dec 30, 2023
Completion
Dec 30, 2024
Last update
Aug 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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