Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy

Malocclusion Clinical Trial

— malocclusion  

Official title:

Evaluation of Efficacy of Clear Aligners in Correction of Class II Malocclusion Using Intermaxillary Elastics: A Randomized Controlled

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05684510
• Other study ID #: Hama University -
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Hama University
• Contact: Fadi Jnaid
• Phone: 988499015
• Email: Drfadijnaid[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances. There are two group: 1. a group of patients in which participants will be undergo to the clear aligners with class ii elastics. 2. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.

Description:

Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances. There are two group: 1. a group of patients in which participants will be undergo to the clear aligners with class ii elastics. 2. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics. phase Intervention/treatment Condition or disease Not applicable Other: clear aligners Technique with class ii elastics. Other: fixed multibracket appliances with class ii elastics Malocclusion Class ii Division 1 malocclusion

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 1, 2024
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 20 Years

Eligibility

Inclusion Criteria:

• - Patients with permanent occlusion at age 15-20 years.
• Patients with class II division I (half cusp or Less) with moderate overjet (2-4mm).
• Patients with normal or horizontal growth pattern.
• Mild crowding (_<2 mm) in maxillary and mandibular arch.
• Patient with satisfactory periodontal health and good oral hygiene
• No previous orthodontic treatment
• Comprehensive medical and dental history ruling out any systemic disease.

Exclusion Criteria:

• Patients with periodontal disease.
• Patients with vertical growth pattern.
• Patients with missing or extracted teeth except third molar.
• Patients with temporomandibular joint disorder.
• Patients with Skeletal open bite.
• Patients with poor oral and gingival health
• Patients with neuromuscular disorder.
• Patients with severe skeletal class II.

Related Conditions & MeSH terms

• Class II Malocclusion
• Malocclusion
• Malocclusion, Angle Class II

Intervention

Device:
• clear aligners
clear aligners will be applied to the upper and lower arch, then a class II elastics 1\4 and 6,5 oz will be use from the precision-cut Hook on the maxillary aligner to the button of mandibular first molar
• traditional treatment Fixed appliances with class II elastics.
Agroup of patients in which participants will be undergo to the fixed multibracket treatment (with slot size 0.022 × 0.028 and MBT prescription , after completing leveling and alignment , Elastics will be applied from the hooks of canines brackets to the hooks of lower first molar when the 0.019× 0.025-inch stainless steel archwires placed.

Locations

Country	Name	City	State
Syrian Arab Republic	Hama University	Hama

Sponsors (1)

Lead Sponsor	Collaborator
Hama University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the SNA angle	This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.	: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group
Primary	change in the SNB angle	This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.	: T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved(expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary	change in ANB angle	This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.	T0:1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary	change in SN.POG angle	This angle the represents the position of the chin bone in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.	: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary	change in the mandibular length [	Amount of distance measured from the Co point to Gn point in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.	T0: 1day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary	change in SN.PP angle [	This angle the represents the amount and direction of rotation of the upper jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.	T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary	change in MP.SN angle	This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.	T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary	change in overjet	Represents The distance between the most anterior point on the lower incisor to the most anterior point on the upper incisor in the cephalometric analysis.	: T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)
Primary	change in overbite	Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis.	T0: 1 day before the beginning of treatment . T1: when a normal overjet and canines class I relationships achieved (expected to be within 4-6 months in the exp. Group and 12 months in the control group)