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NCT Number: NCT05950581

Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates

Patients with skeletal class II malocclusion who have a retracted lower jaw will be treated in this study. The efficacy of clear Plates in the treatment of Skeletal Class II Malocclusion 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.

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Key information

Conditions

Malocclusion, Angle Class II Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

There are two group:

  • a group of patients in which participants will be undergo to Modified Twin-Block Appliance with Clear Plates.
  • a group of patients in which participants will be undergo to the traditional Twin-Block Appliance.

phase Intervention/treatment Condition or disease

Not applicable Other:

Modified Twin-Block Appliance with Clear Plates.

Other:

Traditional Twin-Block Appliance. Skeletal class II Malocclusion

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Patients with mixed dentition at age 10.5-13 years.
  • The patient has Skeletal class II malocclusion caused by mandibular retraction ANB > 5, 8 mm >O.J> 5 mm, SNB<78, angle (NSAr) ≥ ° 125 and normal placement of the upper jaw.
  • The patient is willing to accept treatment with a removable device.
  • No previous orthodontic treatment
  • the growth model is within the normal or horizontal maxillary opening angle of 30 >MM or angle of 400 > Björk
  • patients do not have an upper alveolar dental protrusion.

Exclusion criteria

  • -Patients with periodontal disease.
  • patients with a neuromuscular disorder.
  • patients of class I or III of malocclusion.
  • Patients with temporomandibular joint disorder.
  • Patients with Skeletal open bite.
  • Patients with poor oral and gingival health
  • the presence of a unilateral or bilateral posterior crossbite.
  • patients who have upper jaw stenosis and need to be prepared by expansion before functional treatment.
  • any patient who does not meet one or more of the Inclusion criteria will be removed from the study.

Treatment and study plan

Modified Twin-Block Appliance with Clear Plates.

Device

Clear plates technique A group of patients in which participants will be undergo to clear plates treatment will be applied to the upper and lower arch 17 hours daily

Traditional Twin-Block appliance

Device

Traditional Twin-Block appliance A group of patients in which participants will undergo to the Traditional Twin-Block appliance Treatment, appliances will be applied to the upper and lower arch 17 hours daily

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 6-9 months in the exp. Group and 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 6-9 months in the exp. Group and 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 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 6-9 months in the exp. Group and 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.

  4. 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 6-9 months in the exp. Group and 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.

  5. change in the vertical position of incisors

    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 6-9 months in the exp. Group and control group)

    The vertical distance from the edge of the lower incisor to the mandibular plane.

Study contacts

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

Fadi Jnaid

CONTACT

[email protected]

988499015

Fadi Jnaid

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hama University

Other

Registry information

Official study title

Treatment Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates VS Traditional Twin Block

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 18, 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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