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

Not Applicable

Recruiting

• Conditions: Malocclusion; Class II Malocclusion
• Interventions: Device: clear aligners; Device: traditional treatment Fixed appliances with class II elastics.

• Registration Number: NCT05684510
• Lead Sponsor: Hama University

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-05
• Study First Posted: 2023-01-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Study Start: 2025-08-25
• Primary Completion: 2025-11-11
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental : clear aligners with class II elastics technique	clear aligners	clear aligners technique A group of patients in which participants will be undergo to clear aligners treatment with class II elastics ( 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.	traditional treatment Fixed appliances with class II elastics.	A group 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.

Primary Outcome Measures

Name	Time	Method
change in ANB angle	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)	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.
change in the mandibular length [	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)	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.
change in the SNB angle	: 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)	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.
change in SN.PP angle [	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)	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.
change in overbite	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)	Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis.
Change in the SNA angle	: 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	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.
change in SN.POG angle	: 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)	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.
change in MP.SN angle	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)	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.
change in overjet	: 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)	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.

Trial Locations

Locations (1)

Hama University; 🇸🇾 Hama, Syrian Arab Republic