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

University of Rome Tor Vergata

Status: Completed

Conditions: Class II Malocclusion; IMPA Angle

Treatments: Device: class 2 elastics; Device: clear aligners and elastics

Study type: Interventional

Funder types: Other

Identifiers

NCT06832475

Ethical Commitee n. 24/23

Details and patient eligibility

About

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.

Full 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: ..........)

Enrollment: 40 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Class II malocclusion with clear aligners

Experimental group

Description:

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.

Treatment:

Device: clear aligners and elastics

Device: class 2 elastics

Class II malocclusion with fixed appliance and elastics

Experimental group

Description:

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).

Treatment:

Device: class 2 elastics