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

NCT06832475 | Completed DMC

• 1 other identifier: Ethical Commitee n. 24/23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Class II Malocclusion; IMPA Angle

Outcome Measures

Primary Outcomes (1)

• 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).

  From enrollment to the end of treatment at 18 months

Study Arms (2)

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.

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).

Device: class 2 elastics

Interventions

clear aligners and elastics DEVICE

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).

Also known as: fixed appliance and elastics

Class II malocclusion with clear aligners

class 2 elastics DEVICE

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.

Class II malocclusion with clear aligners; Class II malocclusion with fixed appliance and elastics

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

University of Tor Vergata

Rome, Rome, 00131, Italy

Location

Related Publications (1)

• 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.

  PMID: 40708614 DERIVED

MeSH Terms

Conditions

Overbite

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the partecipants didn't know which type of treatment they will have
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: EFFECTS OF CLASS II ELASTICS DURING TREATMENT WITH CLEAR ALIGNERS VS FIXED APPLIANCE: A RANDOMIZED CLINICAL TRIAL

Model Details: randomized clinical trial, blinded about the type of treatment

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: September 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 15, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

IT (1)