Effects of Class II Elastics During Treatment with Clear Aligners Vs Fixed Appliance: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Comparison between two different devices to solve class II dental malocclusion
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
the partecipants didn't know which type of treatment they will have
Eligibility Criteria
- Ages
- 13 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Class II malocclusion with clear aligners
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.
Intervention: class 2 elastics (Device)
Class II malocclusion with clear aligners
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.
Intervention: clear aligners and elastics (Device)
Class II malocclusion with fixed appliance and elastics
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).
Intervention: class 2 elastics (Device)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Giuseppina Laganà
EFFECTS OF CLASS II ELASTICS DURING TREATMENT WITH CLEAR ALIGNERS VS FIXED APPLIANCE: A RANDOMIZED CLINICAL TRIAL
University of Rome Tor Vergata