Skip to content

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07608302
Enrollment
60
Registered
2026-05-27
Start date
2024-02-13
Completion date
2025-09-19
Last updated
2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narrow Palate

Keywords

Dentoalveolar expansion, clear aligners, predictability

Brief summary

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.

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.

Interventions

DEVICEInvisalign 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).

DEVICEAngel 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).

DEVICEAngel 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)

Sponsors

University of Salamanca
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The study population comprised 60 adult subjects with a mean age of 33.93 ± 8.38 years, presenting with transverse maxillary and mandibular deficiencies requiring dentoalveolar expansion with clear aligners in both arches. All diagnoses were established by a qualified orthodontic specialist. Participants were divided into three homogeneous groups of 20 individuals, each receiving treatment with a distinct clear aligner system. For each subject, digital maxillary and mandibular models were collected in STL format at three distinct time points: at baseline prior to treatment initiation (pretreatment model, T1), at the completion of the virtual treatment setup approximately one month later (planning reference model, T2), and after completion of the initially prescribed aligner sequence, approximately six months thereafter (pre-finishing model, T3). In total, 360 digital models were included in the analysis.

Eligibility

Sex/Gender
ALL
Age
25 Years to 43 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dentoalveolar expansionOne yearChange from baseline in maxillary intermolar width measured in millimeters.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026