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NCT Number: NCT05684510

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

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.

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Key information

Conditions

Malocclusion Class II Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

15 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clear aligners

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.

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.

Primary outcomes

  1. Change in the SNA angle

    Time frame: : 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.

  2. change in the SNB angle

    Time frame: : 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.

  3. change in ANB angle

    Time frame: 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.

  4. change in SN.POG angle

    Time frame: : 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.

  5. change in the mandibular length [

    Time frame: 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.

  6. change in SN.PP angle [

    Time frame: 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.

  7. change in MP.SN angle

    Time frame: 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.

  8. change in overjet

    Time frame: : 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.

  9. change in overbite

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

FATIMA NASHTR, MSc

CONTACT

[email protected]

Fadi Jnaid

CONTACT

[email protected]

988499015

Sponsors and collaborators

Lead sponsor

Hama University

Other

Registry information

Official study title

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

Acronym: malocclusion

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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