Dental CrowdingLIINCT07745855
The Reliability and Validity of Little's Irregularity Index Assessment
An observational study of Dental Crowding and Malocclusion, Angle Class I, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The primary aim of the current study was to estimate the validity, reliability, and repeatability of LII measurements Read more about this study
- Who is it for?
- Ages 13 to 18 years, women only
- Conditions the study is for
- Dental Crowding, Malocclusion, Angle Class I
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Women only
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reliability and Validity of Little's Irregularity Index Assessment Using Three Dimensional (3D) Digital Models and Plaster Model's Photographs: A Reproducibility Study
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.
- Conditions
- Dental Crowding, Malocclusion, Angle Class I
- Keywords
- Little's Irregularity Index
- Medical subject headings
- Crowding, Malocclusion, Angle Class I
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Jun 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CrowdingStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed B.M. Farhat, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745855
- Sponsor's protocol ID
- 653/253
- Acronym
- LII
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After complection of the current study
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of Little's Irregularity Index Assessment Using Three Dimensional (3D) Digital Models and Plaster Model's Photographs: A Reproducibility Study
- ClinicalTrials.gov ID
- NCT07745855
- Acronym / sponsor ID
- LII / 653/253
- Conditions
- Dental Crowding, Malocclusion, Angle Class I
- Keywords
- Little's Irregularity Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the current study was to estimate the validity, reliability, and repeatability of LII measurements
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
validity, reliability, and repeatability of Little's Irregularity Index measurements
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publicationThe 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 dataSharing planned: Yes. After complection of the current study
Related trials for Dental Crowding
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Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
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Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
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Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
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Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Crowding and Malocclusion, Angle Class I, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity, reliability, and repeatability of Little's Irregularity Index measurements (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07745855, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.