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

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: Completed
• Conditions: Narrow Palate
• Intervention / Treatment: Device: Invisalign expansion; Device: Angel Aligner; Device: Angel Aligner Pro

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: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Dentoalveolar expansion	Change from baseline in maxillary intermolar width measured in millimeters.	One year

Collaborators and Investigators

• Sponsor: University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Actual): February 13, 2024
• Study Completion (Actual): September 19, 2025

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: predictability; clear aligners; Dentoalveolar expansion
• Other Study ID 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