Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems

May 20, 2026 updated by: Elena Calzadilla Suárez, University of Salamanca

Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems: Angel Aligner Pro-Angel Aligner and Invisalign. A Longitudinal Clinical Study in Adult Patients.

To analyze the clinical predictability of transverse arch expansion achieved with two clear aligner systems (Invisalign, Angel Aligner-Angel Aligner Pro) by comparing planned and achieved dental movements through digital model analysis at different treatment stages using a repeatable and reproducible digital measurement technique.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study population comprised 60 adult subjects (mean age: 33.93 ± 8.38 years) presenting with transverse maxillary and mandibular deficiencies requiring dentoalveolar expansion with clear aligners in both arches. Participants were divided into three homogeneous groups of 20 patients treated with different aligner systems: Angel Aligner-Angel Aligner Pro (Angelalign Technology Inc., Shanghai, China), and Invisalign (Align Technology Inc., San Jose, CA, USA). Digital models of the maxillary and mandibular arches were obtained at baseline (T1) using an iTero Element 5D intraoral scanner. Virtual treatment planning was performed using iOrtho (version 5.2) and ClinCheck (version 6.0 Pro) software, generating a virtual setup model (T2) that served as the reference for calculating prescribed orthodontic movements. After aligner fabrication, composite attachments were bonded using standardized protocols and manufacturer-provided templates to ensure reproducibility and accurate expression of planned tooth movements. Digital STL models obtained before treatment, after virtual setup, and at the end of treatment were analyzed using a repeatable and reproducible digital measurement technique to evaluate the predictability of transverse dentoalveolar expansion achieved with each aligner system.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Salamanca
      • Salamanca, Salamanca, Spain, 37008
        • University of Salamanca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with a full permanent dentition
  • Absence of auxiliary orthodontic appliances
  • A clinical indication for transverse expansion in both dental arches
  • Complete diagnostic and treatment records
  • Treatment plans involving a minimum of 15 aligners before any refinement phase
  • Confirmed adequate compliance with aligner wear (20-22 hours per day)
  • patients with skeletal Class I or mild skeletal Class II or III relationships (ANB angle ranging from 0° to 4°

Exclusion Criteria:

  • Severe dental crowding (tooth size-arch length discrepancy exceeding -5 mm)
  • Active periodontal pathology
  • Treatment plans involving dental extractions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Invisalign
The Invisalign group consisted of 20 patients treated with Invisalign clear aligners, with each aligner worn for 10 days before progressing to the next stage in the treatment sequence.
Device: Invisalign expansion
Transverse dentoalveolar expansion was performed according to the virtual treatment planning established in the aligner software. Orthodontic movements were progressively achieved through the sequential use of the planned clear aligner (an aligner per step).
Experimental: Angel aligner
The Angel Aligner group consisted of 20 patients treated with Angel Aligner clear aligners, with each aligner worn for 10 days before progressing to the next stage in the treatment sequence.
Device: Angel Aligner
Transverse dentoalveolar expansion was performed according to the virtual treatment planning established in the aligner software. Orthodontic movements were progressively achieved through the sequential use of the planned clear aligners (an aligner per step).
Experimental: Angel Aligner pro
The Angel Aligner Pro group consisted of 20 patients treated with Angel Aligner clear aligners. Each treatment stage included two aligners: an initial softer aligner worn for 7 days, followed by a second, more rigid aligner worn for 3 days before progressing to the next stage in the treatment sequence.
Device: Angel Aligner Pro
Transverse dentoalveolar expansion was performed according to the virtual treatment planning established in the aligner software. Orthodontic movements were progressively achieved through the sequential use of the planned clear aligners (an initial softer aligner worn for 7 days, followed by a second, more rigid aligner worn for 3 days before progressing to the next stage in the treatment sequence)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dentoalveolar expansion
Time Frame: One year
Change from baseline in maxillary intermolar width measured in millimeters.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Salamanca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UniversidadDSalamanca

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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