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

NCT07608302 | Completed

• 1 other identifier: UniversidadDSalamanca
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Narrow Palate

Keywords

Dentoalveolar expansion; clear aligners; predictability

Outcome Measures

Primary Outcomes (1)

• Dentoalveolar expansion

  Change from baseline in maxillary intermolar width measured in millimeters.

  One year

Study Arms (3)

Invisalign

EXPERIMENTAL

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

Angel aligner

EXPERIMENTAL

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

Angel Aligner pro

EXPERIMENTAL

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

Interventions

Invisalign expansion DEVICE

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).

Invisalign

Angel Aligner DEVICE

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).

Angel aligner

Angel Aligner Pro DEVICE

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)

Angel Aligner pro

Eligibility Criteria

• Age: 25 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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°

You may not qualify if:

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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

University of Salamanca

Salamanca, Salamanca, 37008, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 27, 2026
• Study Start: February 13, 2024
• Primary Completion: February 13, 2024
• Study Completion: September 19, 2025
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)