NCT06832475

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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

Conditions

• Class II Malocclusion
• IMPA Angle

Interventions

Type	Name	Description
DEVICE	clear aligners 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).
DEVICE	class 2 elastics	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.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-06-30
• Completion: 2024-12-15
• First posted: 2025-02-18
• Last updated: 2025-02-18

Locations

1 site across 1 country: Italy