NCT05684510

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. 1.a group of patients in which participants will be undergo to the clear aligners with class ii elastics.
  2. 2.a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
3.6 years until next milestone

Study Start

First participant enrolled

August 25, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2026

20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

January 5, 2023

Last Update Submit

September 9, 2025

Conditions

MalocclusionClass II Malocclusion

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Experimental : clear aligners with class II elastics technique

EXPERIMENTAL

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

: traditional treatment Fixed appliances with class II elastics.

EXPERIMENTAL

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

clear alignersDEVICE

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

Experimental : clear aligners with class II elastics technique
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.

: traditional treatment Fixed appliances with class II elastics.

Eligibility Criteria

Age15 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hama University

Hama, Hama Governorate, Syria

RECRUITING

MeSH Terms

Conditions

MalocclusionOverbite

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesMalocclusion, Angle Class II

Study Officials

  • FATIMA NASHTR, MSc

    Hama University

    PRINCIPAL INVESTIGATOR

  • Rabab AlSabbag, Professor

    Hama University

    STUDY DIRECTOR

Central Study Contacts

Fadi Jnaid

CONTACT

988499015Drfadijnaid@gmail.com

FATIMA NASHTR, MSc

CONTACT

fatimahnashtar96@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Syria-Hama University

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start (Estimated)

August 25, 2026

Primary Completion (Estimated)

November 11, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

SY(1)