Malocclusion Class IINCT07591025
Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients
A study testing AngelAligner A6 Mandibular Advancer, Twin Block and Clear aligners in people with Malocclusion Class II, run by University of Salamanca at 1 site in Spain.
Trial summary
To analyze mandibular advancement between the traditional Twin Block and the Angel Aligner A6 mandibular advancement clear aligners using cephalometric analysis in growing patients and a repeatable and reproducible digital measurement technique. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Malocclusion Class II
- What is being tested?
- AngelAligner A6 Mandibular Advancer, Twin Block and Clear aligners
- 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
- 18 Oct 2022to 14 Jul 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 9 and 14 years with late mixed or early permanent dentition
- Class II/1 malocclusion (molar relationship ≥ half-cusp Class II and overjet ≥ 5 mm)
- ANB angle greater than 5º
- SNB lower than 78º
- CVMS 2-3, a growing patients.
Who cannot join
- Previous orthodontic treatment or orthognathic surgery
- Patients with severe malformations or syndromes
- Extraction treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Efficacy of AngelAligner A6 Mandibular Advancer and Twin Block in the Treatment of Class II Malocclusion in Growing Patients: a Prospective Clinical Study
To analyze mandibular advancement between the traditional Twin Block and the Angel Aligner A6 mandibular advancement clear aligners using cephalometric analysis in growing patients and a repeatable and reproducible digital measurement technique.
Read the detailed description
This study compared three early orthodontic treatments for Class II division 1 malocclusion in 60 growing patients (mean age: 12.4 ± 1.3 years): Twin Block, standard Angel Aligner, and Angel Aligner A6 with mandibular advancement.
After 10 months, both Twin Block and A6 showed greater skeletal correction and mandibular advancement than standard aligners, achieving higher rates of Class I correction. The A6 group also had the shortest overall treatment time.
Cephalometric analyses were performed using a digital and reproducible measurement technique. For each patient, lateral cephalograms were taken before treatment (T0) and after treatment (T1, after the functional phase or aligner completion). Thus, a total of 120 lateral cephalograms were analysed. The following skeletal, dental, and soft tissue parameters were analysed.
- Conditions
- Malocclusion Class II
- Being tested
- AngelAligner A6 Mandibular Advancer, Twin Block, Clear aligners
- Keywords
- Class II, mandibular advancement, clear aligners, twin block, growing patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngelAligner A6 Mandibular AdvancerDevice
Also called GA6
Mandibular advancement with aligners is achieved using specially designed orthodontic aligners that incorporate built-in mandibular advancement features. These appliances posture the lower jaw forward in a controlled and incremental manner while simultaneously aligning the teeth. The forward positioning of the mandible helps stimulate mandibular growth in growing patients and improves the correction of Class II malocclusion by enhancing sagittal jaw relationship. Aligner replacement was performed at 10-day intervals.
Twin BlockDevice
The Twin Block is a removable functional orthodontic appliance used to correct Class II malocclusion by advancing the mandible. It consists of upper and lower acrylic plates with bite blocks that interlock at a specific angle, guiding the lower jaw forward during closure. It is most effective in growing patients to improve jaw relationship and facial profile. The Twin Block appliance, used for mandibular advancement (correction of skeletal class II), was usually worn for a period of 10 months, with a minimum of 14-16 hours per day, including night hours.
Clear alignersDevice
Class II correction with aligners (without mandibular advancement) involves the use of clear sequential aligners to improve dental alignment and occlusion by moving teeth into a more favorable position. The correction is achieved through controlled tooth movements such as distalization, interproximal reduction, and vertical control, without actively repositioning the mandible forward.
| Study group | Role | What they receive |
|---|---|---|
| AngelAligner A6 Mandibular Advancer | Experimental | Mandibular advancement with aligners uses specially designed appliances to position the lower jaw forward, improving jaw alignment and correcting Class II malocclusion in growing patients. Aligner replacement was performed at 10-day intervals. Receives: Device: AngelAligner A6 Mandibular Advancer |
| Twin block | Active comparator | The Twin Block is a removable functional orthodontic appliance used to correct Class II malocclusion by advancing the mandible. It consists of upper and lower acrylic plates with bite blocks that interlock at a specific angle, guiding the lower jaw forward during closure. It is most effective in growing patients to improve jaw relationship and facial profile. The Twin Block appliance was worn for a period of 10 months, with a minimum of 14-16 hours per day, including night hours. Receives: Device: Twin Block |
| Clear aligners | Active comparator | Class II correction with aligners (without mandibular advancement) involves the use of clear sequential aligners to improve dental alignment and occlusion by moving teeth into a more favorable position. The correction is achieved through controlled tooth movements without actively repositioning the mandible forward. Aligner replacement was performed at 10-day intervals. Receives: Device: Clear aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
ANB (°)
Point A-nasion-point B angle (ANB): relationship between the upper and lower jaws
Measured: 10 months
Wits appraisal (AO-BO)
projecting points A and B in two perpendicular lines, along the functional occlusal plane
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start18 Oct 2022
- Primary completion18 Oct 2022
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malocclusion Class IIStudies 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 is designed as a parallel-group interventional trial with three independent treatment arms. A total of 60 participants (mean age: 12.4 ± 1.3 years) will be enrolled and allocated equally into one of three orthodontic interventions (Twin Block, standard Angel Aligner, or Angel Aligner A6 with mandibular advancement), with 20 patients per group. Each participant receives only the assigned treatment throughout the study period, with no crossover between groups. Outcomes are assessed at baseline (T0) and after 10 months of treatment (T1) using digital cephalometric 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
- NCT07591025
- Sponsor's protocol ID
- UniversidadDeSalamanca
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scuzzo G, Scuzzo G, Calzadilla-Suarez E, Alvarado-Lorenzo M, Criado-Perez L, Curto A, Alvarado-Lorenzo A. Analysis of the efficacy of AngelAligner A6 mandibular advancer and Twin Block in the treatment of class II malocclusion in growing patients: a prospective clinical study. BMC Oral Health. 2026 Sep 19;26(1):1788. doi: 10.1186/s12903-026-09565-z.
PubMed 42773450
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy of AngelAligner A6 Mandibular Advancer and Twin Block in the Treatment of Class II Malocclusion in Growing Patients: a Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07591025
- Acronym / sponsor ID
- UniversidadDeSalamanca
- Conditions
- Malocclusion Class II
- Keywords
- Class II, mandibular advancement, clear aligners, twin block, growing patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 15 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 mandibular advancement between the traditional Twin Block and the Angel Aligner A6 mandibular advancement clear aligners using cephalometric analysis in growing patients and a repeatable and reproducible digital measurement technique.
Detailed description
This study compared three early orthodontic treatments for Class II division 1 malocclusion in 60 growing patients (mean age: 12.4 ± 1.3 years): Twin Block, standard Angel Aligner, and Angel Aligner A6 with mandibular advancement.
After 10 months, both Twin Block and A6 showed greater skeletal correction and mandibular advancement than standard aligners, achieving higher rates of Class I correction. The A6 group also had the shortest overall treatment time.
Cephalometric analyses were performed using a digital and reproducible measurement technique. For each patient, lateral cephalograms were taken before treatment (T0) and after treatment (T1, after the functional phase or aligner completion). Thus, a total of 120 lateral cephalograms were analysed. The following skeletal, dental, and soft tissue parameters were analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study is designed as a parallel-group interventional trial with three independent treatment arms. A total of 60 participants (mean age: 12.4 ± 1.3 years) will be enrolled and allocated equally into one of three orthodontic interventions (Twin Block, standard Angel Aligner, or Angel Aligner A6 with mandibular advancement), with 20 patients per group. Each participant receives only the assigned treatment throughout the study period, with no crossover between groups. Outcomes are assessed at baseline (T0) and after 10 months of treatment (T1) using digital cephalometric analysis.
| Arm | Type | Receives |
|---|---|---|
| AngelAligner A6 Mandibular Advancer | Experimental | Device: AngelAligner A6 Mandibular AdvancerMandibular advancement with aligners uses specially designed appliances to position the lower jaw forward, improving jaw alignment and correcting Class II malocclusion in growing patients. Aligner replacement was performed at 10-day intervals. |
| Twin block | Active comparator | Device: Twin BlockThe Twin Block is a removable functional orthodontic appliance used to correct Class II malocclusion by advancing the mandible. It consists of upper and lower acrylic plates with bite blocks that interlock at a specific angle, guiding the lower jaw forward during closure. It is most effective in growing patients to improve jaw relationship and facial profile. The Twin Block appliance was worn for a period of 10 months, with a minimum of 14-16 hours per day, including night hours. |
| Clear aligners | Active comparator | Device: Clear alignersClass II correction with aligners (without mandibular advancement) involves the use of clear sequential aligners to improve dental alignment and occlusion by moving teeth into a more favorable position. The correction is achieved through controlled tooth movements without actively repositioning the mandible forward. Aligner replacement was performed at 10-day intervals. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged between 9 and 14 years with late mixed or early permanent dentition
- Class II/1 malocclusion (molar relationship ≥ half-cusp Class II and overjet ≥ 5 mm)
- ANB angle greater than 5º
- SNB lower than 78º
- CVMS 2-3, a growing patients.
Key exclusion criteria (3 listed)
- Previous orthodontic treatment or orthognathic surgery
- Patients with severe malformations or syndromes
- Extraction treatment.
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 |
|---|---|---|
| AngelAligner A6 Mandibular AdvancerAlso: GA6Mandibular advancement with aligners is achieved using specially designed orthodontic aligners that incorporate built-in mandibular advancement features. These appliances posture the lower jaw forward in a controlled and incremental manner while simultaneously aligning the teeth. The forward positioning of the mandible helps stimulate mandibular growth in growing patients and improves the correction of Class II malocclusion by enhancing sagittal jaw relationship. Aligner replacement was performed at 10-day intervals. | Device | AngelAligner A6 Mandibular Advancer |
| Twin BlockThe Twin Block is a removable functional orthodontic appliance used to correct Class II malocclusion by advancing the mandible. It consists of upper and lower acrylic plates with bite blocks that interlock at a specific angle, guiding the lower jaw forward during closure. It is most effective in growing patients to improve jaw relationship and facial profile. The Twin Block appliance, used for mandibular advancement (correction of skeletal class II), was usually worn for a period of 10 months, with a minimum of 14-16 hours per day, including night hours. | Device | Twin block |
| Clear alignersClass II correction with aligners (without mandibular advancement) involves the use of clear sequential aligners to improve dental alignment and occlusion by moving teeth into a more favorable position. The correction is achieved through controlled tooth movements such as distalization, interproximal reduction, and vertical control, without actively repositioning the mandible forward. | Device | Clear aligners |
Primary outcome
ANB (°)
Time frame: 10 months
Point A-nasion-point B angle (ANB): relationship between the upper and lower jaws
Wits appraisal (AO-BO)
Time frame: 10 months
projecting points A and B in two perpendicular lines, along the functional occlusal plane
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 15 May 2026.
- Derived from this study: PubMed 42773450Scuzzo G, Scuzzo G, Calzadilla-Suarez E, Alvarado-Lorenzo M, Criado-Perez L, Curto A, Alvarado-Lorenzo A. Analysis of the efficacy of AngelAligner A6 mandibular advancer and Twin Block in the treatment of class II malocclusion in growing patients: a prospective clinical study. BMC Oral Health. 2026 Sep 19;26(1):1788. doi: 10.1186/s12903-026-09565-z.
- 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 AngelAligner A6 Mandibular Advancer, Twin Block and Clear aligners in people with Malocclusion Class II, 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 5 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 15 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?
ANB (°) (time frame: 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07591025, which also lists 1 linked publication.
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 15 May 2026.