Narrow PalateNCT07608302
Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems
A study testing Invisalign expansion, Angel Aligner and Angel Aligner Pro in people with Narrow Palate, run by University of Salamanca at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 43 years
- Conditions the study is for
- Narrow Palate
- What is being tested?
- Invisalign expansion, Angel Aligner and Angel Aligner Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 13 Feb 2024to 19 Sep 2025
- Phase
- Interventional
- 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 25 to 43 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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°
Who cannot join
- Severe dental crowding (tooth size-arch length discrepancy exceeding -5 mm)
- Active periodontal pathology
- Treatment plans involving dental extractions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Narrow Palate
- Being tested
- Invisalign expansion, Angel Aligner, Angel Aligner Pro
- Keywords
- Dentoalveolar expansion, clear aligners, predictability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invisalign expansionDevice
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).
Angel AlignerDevice
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 ProDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Angel Aligner Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dentoalveolar expansion
Change from baseline in maxillary intermolar width measured in millimeters.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start13 Feb 2024
- Primary completion13 Feb 2024
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narrow PalateStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Calzadilla Suárez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608302
- Sponsor's protocol ID
- UniversidadDSalamanca
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07608302
- Acronym / sponsor ID
- UniversidadDSalamanca
- Conditions
- Narrow Palate
- Keywords
- Dentoalveolar expansion, clear aligners, predictability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 27 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Invisalign | Experimental | Device: Invisalign expansionThe 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. |
| Angel aligner | Experimental | Device: Angel AlignerThe 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. |
| Angel Aligner pro | Experimental | Device: Angel Aligner ProThe 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. |
Who may qualify
- Ages
- 25 to 43 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Severe dental crowding (tooth size-arch length discrepancy exceeding -5 mm)
- Active periodontal pathology
- Treatment plans involving dental extractions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invisalign expansionTransverse 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). | Device | Invisalign |
| Angel AlignerTransverse 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). | Device | Angel aligner |
| Angel Aligner ProTransverse 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) | Device | Angel Aligner pro |
Primary outcome
Dentoalveolar expansion
Time frame: One year
Change from baseline in maxillary intermolar width measured in millimeters.
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 27 May 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Invisalign expansion, Angel Aligner and Angel Aligner Pro in people with Narrow Palate, run by University of Salamanca at 1 site in Spain.
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 7 inclusion and 3 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 27 May 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 Spain. 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?
Dentoalveolar expansion (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.