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

NCT06832475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Class II Malocclusion
  • IMPA Angle

Interventions

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.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-06-30
Completion
2024-12-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06832475 on ClinicalTrials.gov