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RecruitingNCT05684510malocclusionUpdated Sep 16, 2026

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

An interventional study of clear aligners and traditional treatment Fixed appliances with class II elastics. in Malocclusion and Class II Malocclusion, sponsored by Hama University. Recruiting at 1 site in Syria. Open to participants aged 15 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Hama University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
15 Years to 20 Years
Sex
All
01

Study 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.
Read the 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

02

Conditions studied

  • Malocclusion
  • Class II Malocclusion

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03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 24 is below the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Hama University is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    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

    Device: clear aligners

  • Experimental
    : 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.

    Device: traditional treatment Fixed appliances with class II elastics.

Interventions

  • Deviceclear 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

  • Devicetraditional 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.

06

What researchers measure

Primary outcomes

  1. 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.

    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

  2. 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.

    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)

  3. 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.

    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)

  4. 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.

    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)

  5. 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.

    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)

  6. 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.

    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)

  7. 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.

    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)

  8. 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.

    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)

  9. change in overbite

    Amount of coverage the upper incisor to lower incisor in the vertical plane in the cephalometric analysis.

    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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05684510
Lead sponsor
Hama University
Responsible party
FADI JNAID (Syria-Hama University, Hama University) — Principal investigator
First posted
Jan 13, 2023
Start date
Aug 25, 2026 (estimated)
Primary completion
Nov 11, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Sep 16, 2026

Study contacts

Fadi Jnaid
Contact
Drfadijnaid@gmail.com
988499015
FATIMA NASHTR, MSc
Contact
fatimahnashtar96@gmail.com
FATIMA NASHTR, MSc
principal investigator · Hama University
Rabab AlSabbag, Professor
study director · Hama University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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