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

NCT ID: NCT05684510

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-25
• Study Completion Date: 2026-12-01

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

Conditions

Malocclusion; Class II Malocclusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental : clear aligners with class II elastics technique

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

Group Type: EXPERIMENTAL

clear aligners

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

traditional treatment Fixed appliances with class II elastics.

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hama University

OTHER

Sponsor Role: lead

Responsible Party

FADI JNAID

Syria-Hama University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

FATIMA NASHTR, MSc

Role: PRINCIPAL_INVESTIGATOR

Hama University

Rabab AlSabbag, Professor

Role: STUDY_DIRECTOR

Hama University

Locations

Hama University

Hama, Hama Governorate, Syria

Site Status: RECRUITING

Countries

Syria

Central Contacts

Fadi Jnaid

Role: CONTACT

Drfadijnaid@gmail.com

988499015

FATIMA NASHTR, MSc

Role: CONTACT

fatimahnashtar96@gmail.com

Facility Contacts

Fadi Jnaid

Role: primary

Drfadijnaid@gmail.com

988499015

FATIMA NASHTR

Role: backup

fatimahnashtar96@gmail.com

Other Identifiers

Hama University -

Identifier Type: -

Identifier Source: org_study_id