Class II MalocclusionClass IINCT06832475

Comparing the Impact of Rubber Bands on Teeth Straightening with Clear Aligners Versus Traditional Braces: a Clinical Study

A study testing clear aligners and elastics and class 2 elastics in people with Class II Malocclusion and IMPA Angle, run by University of Rome Tor Vergata at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 to 17 years
Conditions the study is for: Class II Malocclusion, IMPA Angle
What is being tested?: clear aligners and elastics and class 2 elastics
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteItaly
Study dates: 1 Sep 2023to 15 Dec 2024
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 13 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no or moderate crowding (0- 3 mm) no history of orthodontic treatment.

Who cannot join

not completed permanent dentition, skeletal Class II or dental Class II more than 4 mm, crowding more than 3 mm, subjects already treated with iother orthodontic appliances.

Trial locations and contacts

1 site in 1 country.

Italy1 site

University of Tor Vergata
Rome, Rome, 00131

Other trials in Italy

About this study

Official title: Effects of Class II Elastics During Treatment with Clear Aligners Vs Fixed Appliance: a Randomized Clinical Trial

Aim: To analyze the inclination of lower incisors in patients with Class II malocclusion treated with elastics and clear aligners compared to a group wearing the same elastics and fixed appliance. A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years, was randomly divided in two groups: Clear aligner group (CA), Fixed appliance group (FA). The subjects were selected according to inclusion criteria: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no history of orthodontic treatment.

Read the detailed description

Trial design: Prospective two-arms parallel group randomized clinical trial with 1:1 allocation ratio.

Materials and Methods: A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years, was collected from the Department of Orthodontics at Policlinico "Tor Vergata" of Rome, and it was randomly divided in two groups: Clear aligner group (CA), Fixed appliance group (FA). The subjects were selected according to inclusion criteria: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no history of orthodontic treatment. Results: In the short term (T1-T0=18 months), the analysis of the results showed no statistically significant changes in all evaluated parameters. Therefore, there is no statistically significant change in the inclination of the lower incisors between the two groups.

Conclusions: The use of Class II elastics in CA group showed a better control of the lower incisors' inclination, compared to the FA group, even if the difference is not significant.

Trial registration: ClinicalTrials.gov (registration number: ..........)

Conditions: Class II Malocclusion, IMPA Angle
Being tested: clear aligners and elastics, class 2 elastics
Medical subject headings: Overbite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

clear aligners and elasticsDevice
Also called fixed appliance and elastics
For the Fixed Appliance group, the straight wire treatment included an aligning and leveling phase, achieved by using Nickel-Titanium arches (0.016/0.019 × 0.025 arc sequence) and a phase with heavier stainless steel rectangular arches (0.019 × 0.025); during this last treatment phase patients were instructed to use Class II elastics for at least 16 h/day.
Pre- (T0) and post-treatment (T1) lateral cephalogram were collected from all selected patients. Treatment time was an average of 18 months (T1-T0=18 months).
class 2 elasticsDevice
Class II malocclusion is the most common malocclusion, and it is one of the main reasons for people to undergo orthodontic treatment. This alteration is characterized by an improper relationship between the maxillary and mandibular arches because of skeletal or dental discrepancies or a combination of both . The treatment protocols may considerably vary depending on professional skills, malocclusion severity and patient compliance . Among all the well-known techniques, it is important to mention the Class II elastics , used to camouflage mild skeletal Class II or to treat mild to moderate Class II occlusal relationship.
During the correction of Class II malocclusions by means of inter-arch elastics, special attention should be paid to the position of the lower incisors.

Study groups in NCT06832475
Study group	Role	What they receive
Class II malocclusion with clear aligners	Experimental	For the groupteated with Clear Aligners (CA), the treatment provided the application of Invisalign clear aligner system and the absence of any other auxiliaries apart from Invisalign optimized attachments. Each subject was instructed to wear aligners for 22 hours per day, except during meals and oral hygiene procedures and to replace aligners once a week, always the same day of the week. Every six stages the clinician personally checked the good aligner fitting, the position of the attachments and the patient collaboration. Receives: Device: clear aligners and elastics; Device: class 2 elastics
Class II malocclusion with fixed appliance and elastics	Experimental	For the group treated with Fixed Appliance (FA), the straight wire treatment included an aligning and leveling phase, achieved by using Nickel-Titanium arches (0.016/0.019 × 0.025 arc sequence) and a phase with heavier stainless steel rectangular arches (0.019 × 0.025); during this last treatment phase patients were instructed to use Class II elastics for at least 16 h/day. Pre- (T0) and post-treatment (T1) lateral cephalogram were collected from all selected patients. Treatment time was an average of 18 months (T1-T0=18 months). Receives: Device: class 2 elastics

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison between two different devices to solve class II dental malocclusion
A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years was collected from the Department of Orthodontics at Policlinico "Tor Vergata" of Rome, from September 2023 to June 2024. The sample was randomly divided in two groups: FA group (Fixed Appliance), consisted of 20 patients (9 M, 11F) treated by straight-wire fixed appliance and Class II elastics: CA group (Clear Aligners), consisted of 20 patients (9M, 11F) treated by Comprehensive Package Invisalign® system and Class II elastics. For both FA and CA groups, the inclusion criteria were the following: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no or moderate crowding (0- 3 mm) no history of orthodontic treatment.
Pre- (T0) and post-treatment (T1) lateral cephalogram were collected from all selected patients. Treatment time was an average of 18 months (T1-T0=18 months).
Measured: From enrollment to the end of treatment at 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202315 Dec 2024

First posted18 Feb 2025
Study start1 Sep 2023
Primary completion30 Jun 2024
Study completion15 Dec 2024

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 Class II MalocclusionStudies 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: Randomised
Intervention model: Parallel groups
Model description: randomized clinical trial, blinded about the type of treatment
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06832475
Sponsor's protocol ID: Ethical Commitee n. 24/23
Acronym: Class II
Status last verified: Feb 2025
First submitted: 13 Feb 2025
Last updated: 18 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Lagana G, Malara A, Lione R, Bollero P, Cozza P. Effects of Class II elastics on lower incisors during treatment with clear aligners vs. fixed appliance: a randomized clinical trial. Front Dent Med. 2025 Jul 10;6:1613037. doi: 10.3389/fdmed.2025.1613037. eCollection 2025.
PubMed 40708614

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children

All Class II Malocclusion trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Class II Elastics During Treatment with Clear Aligners Vs Fixed Appliance: a Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06832475
Acronym / sponsor ID: Class II / Ethical Commitee n. 24/23
Conditions: Class II Malocclusion, IMPA Angle
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of Rome Tor VergataUniversity, hospital or other
Study start: 1 Sep 2023 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 15 Dec 2024 (actual)
First posted: 18 Feb 2025 (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.

Detailed description

Trial design: Prospective two-arms parallel group randomized clinical trial with 1:1 allocation ratio.

Conclusions: The use of Class II elastics in CA group showed a better control of the lower incisors' inclination, compared to the FA group, even if the difference is not significant.

Trial registration: ClinicalTrials.gov (registration number: ..........)

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: randomized clinical trial, blinded about the type of treatment

Arm	Type	Receives
Class II malocclusion with clear aligners	Experimental	Device: clear aligners and elastics, Device: class 2 elasticsFor the groupteated with Clear Aligners (CA), the treatment provided the application of Invisalign clear aligner system and the absence of any other auxiliaries apart from Invisalign optimized attachments. Each subject was instructed to wear aligners for 22 hours per day, except during meals and oral hygiene procedures and to replace aligners once a week, always the same day of the week. Every six stages the clinician personally checked the good aligner fitting, the position of the attachments and the patient collaboration.
Class II malocclusion with fixed appliance and elastics	Experimental	Device: class 2 elasticsFor the group treated with Fixed Appliance (FA), the straight wire treatment included an aligning and leveling phase, achieved by using Nickel-Titanium arches (0.016/0.019 × 0.025 arc sequence) and a phase with heavier stainless steel rectangular arches (0.019 × 0.025); during this last treatment phase patients were instructed to use Class II elastics for at least 16 h/day. Pre- (T0) and post-treatment (T1) lateral cephalogram were collected from all selected patients. Treatment time was an average of 18 months (T1-T0=18 months).

Who may qualify

Ages: 13 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no or moderate crowding (0- 3 mm) no history of orthodontic treatment.

Key exclusion criteria (1 listed)

not completed permanent dentition, skeletal Class II or dental Class II more than 4 mm, crowding more than 3 mm, subjects already treated with iother orthodontic appliances.

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
clear aligners and elasticsAlso: fixed appliance and elasticsFor the Fixed Appliance group, the straight wire treatment included an aligning and leveling phase, achieved by using Nickel-Titanium arches (0.016/0.019 × 0.025 arc sequence) and a phase with heavier stainless steel rectangular arches (0.019 × 0.025); during this last treatment phase patients were instructed to use Class II elastics for at least 16 h/day. Pre- (T0) and post-treatment (T1) lateral cephalogram were collected from all selected patients. Treatment time was an average of 18 months (T1-T0=18 months).	Device	Class II malocclusion with clear aligners
class 2 elasticsClass II malocclusion is the most common malocclusion, and it is one of the main reasons for people to undergo orthodontic treatment. This alteration is characterized by an improper relationship between the maxillary and mandibular arches because of skeletal or dental discrepancies or a combination of both . The treatment protocols may considerably vary depending on professional skills, malocclusion severity and patient compliance . Among all the well-known techniques, it is important to mention the Class II elastics , used to camouflage mild skeletal Class II or to treat mild to moderate Class II occlusal relationship. During the correction of Class II malocclusions by means of inter-arch elastics, special attention should be paid to the position of the lower incisors.	Device	Class II malocclusion with clear aligners, Class II malocclusion with fixed appliance and elastics

Primary outcome

Comparison between two different devices to solve class II dental malocclusion
Time frame: From enrollment to the end of treatment at 18 months
A sample of 40 patients (19M and 21F), mean age 15.4±1.8 years was collected from the Department of Orthodontics at Policlinico "Tor Vergata" of Rome, from September 2023 to June 2024. The sample was randomly divided in two groups: FA group (Fixed Appliance), consisted of 20 patients (9 M, 11F) treated by straight-wire fixed appliance and Class II elastics: CA group (Clear Aligners), consisted of 20 patients (9M, 11F) treated by Comprehensive Package Invisalign® system and Class II elastics. For both FA and CA groups, the inclusion criteria were the following: full permanent dentition (excluding third molars), Class II molar relationship (2,5-4 mm), no or moderate crowding (0- 3 mm) no history of orthodontic treatment. Pre- (T0) and post-treatment (T1) lateral cephalogram were collected from all selected patients. Treatment time was an average of 18 months (T1-T0=18 months).

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 18 Feb 2025.
Derived from this study: PubMed 40708614Lagana G, Malara A, Lione R, Bollero P, Cozza P. Effects of Class II elastics on lower incisors during treatment with clear aligners vs. fixed appliance: a randomized clinical trial. Front Dent Med. 2025 Jul 10;6:1613037. doi: 10.3389/fdmed.2025.1613037. eCollection 2025.

Related trials for Class II Malocclusion

Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
Recruiting
Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
Recruiting
Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
Recruiting
Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children

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 clear aligners and elastics and class 2 elastics in people with Class II Malocclusion and IMPA Angle, run by University of Rome Tor Vergata at 1 site in Italy.

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 1 inclusion and 1 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 18 Feb 2025. 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 Italy. 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?

Comparison between two different devices to solve class II dental malocclusion (time frame: From enrollment to the end of treatment at 18 months). 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 NCT06832475, 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 18 Feb 2025.