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Completed

NCT Number: NCT06832475

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

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.

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Key information

Conditions

Class II Malocclusion IMPA Angle Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tor Vergata

Rome, 00131, Italy

About this study

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: ..........)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Other names: fixed appliance and elastics

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Registry information

Official study title

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

Acronym: Class II

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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