Early Versus Late Intermaxillary Elastics in Patients With Class II Malocclusion

NCT06232928 | Completed FDA Device

• 1 other identifier: AinShamU
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aimed to compare the effect of immediate light short Class II elastics versus conventional Class II elastics on the skeletal, dental and soft tissues in patients with Class II malocclusion. Participants with class II malocclusion divided into 2 groups; early group wore immediate light short Class II elastics and conventional group wore conventional Class II elastics on rigid stainless steel arch wires.

Conditions

Class II Malocclusion Division 1

Keywords

Class II malocclusion; early Class II elastics; conventional Class II elastics

Outcome Measures

Primary Outcomes (1)

• the change of the maxillary incisors inclination

  The primary outcome of this study was to compare the effect of early light short elastics versus conventional elastics on the inclination of upper incisors in patients with canine Class II malocclusion. the Sella-Nasion angle was measured " cephalometric radiographic analysis" in degrees. the angle representing the maxillary incisors inclination "S-N angle" was measured before and after treatment by both protocols, then the amount of changes were compared.

  from the beginning of the treatment till treatment was done about 15 months

Secondary Outcomes (3)

• the 3-dimensional effects of early light short Class II elastics versus conventional elastics on dental, skeletal, and soft tissues.

  from the beginning of the treatment till treatment was done about 15 months

• amount of gingival display during smile

  from the beginning of the treatment till treatment was done about 15 months

• treatment duration

  from the beginning of the treatment till treatment was done about 15 months

Study Arms (2)

1-Early group

EXPERIMENTAL

for the early group, patients were instructed to wear immediate light short Class II elastics from upper canines to lower second premolars for 24 hours except while eating and change the elastics every 12 hours.

Device: Early Class II elastics

2-Conventional group

ACTIVE COMPARATOR

for the conventional group, conventional class II elastics were used on rigid stainless steel arch wires. patients were instructed to wear Class II elastics from upper canines to lower first molars for 24 hours except while eating and change the elastics every 12 hours.

Device: Conventional Class II elastics

Interventions

Early Class II elastics DEVICE

Participants were treated by a fixed orthodontic appliance with intermaxillary class II elastics to correct the class II malocclusion. patients were instructed to wear immediate light short Class II elastics from upper canines to lower second premolars for 24 hours except while eating and change the elastics every 12 hours.

1-Early group

Conventional Class II elastics DEVICE

patients were treated by a fixed orthodontic appliance with intermaxillary Class II elastics. patients were instructed to wear Class II elastics from upper canines to lower first molars for 24 hours except while eating and change the elastics every 12 hours after reaching to rigid stainless steel arch wires.

2-Conventional group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent dentition stage with fully erupted permanent teeth (excluding third molars).
• Patients with increased overjet.
• Patients with canine Class II malocclusion.
• Treatment plan involves the use of a pre-adjusted edgewise fixed orthodontic appliance with a non-extraction approach.

You may not qualify if:

• Patients with a gummy smile.
• Obvious periodontal disease and gingival recession.
• Vulnerable patients (orphans, subjects with mental disorders…. etc.).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, El-Abasaya, 7154411, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II; Overbite

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: January 31, 2024
• Study Start: April 1, 2021
• Primary Completion: February 23, 2023
• Study Completion: June 10, 2023
• Last Updated: January 31, 2024

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: no limit

Locations

EG (1)