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

Not Applicable

Completed

• Conditions: Class II Malocclusion; IMPA Angle

• Registration Number: NCT06832475
• Lead Sponsor: University of Rome Tor Vergata

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.

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

Study Timeline

• Study Start: 2023-09-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-15
• Status Verified: 2025-02
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Last Update Submitted: 2025-02-13
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison between two different devices to solve class II dental malocclusion	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).

Trial Locations

Locations (1)

University of Tor Vergata; 🇮🇹 Rome, Italy