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NCT Number: NCT06631235

Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II

The goal of this is to evaluate the skeletal, dental and soft tissue effects between aesthetic functional appliance and Twin block appliance in treatment of skeletal class II in ( growing male/female patients)

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location contact

Rana Ka Abozeid, Doctor

CONTACT

[email protected]

01009389116

About this study

The sample will be randomly divided into 2 equal groups according to the appliance will be used:

Group 1: Aesthetic Functional appliance Group 2: Twin block

Methods:

*Radiographs (CBCT) will be taken before starting the treatment (T1) and after obtaining Class I occlusion and normal overjet (T2) by sequential appliances.

appliances.

  • Lateral cephalograms -extracted from CBCT- will be used to evaluate the effect of the two appliances.
  • CBCT will be used to evaluate root resorption and bony changes in the condyle .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Skeletal Class II pattern with ANB angle exceeding 6° and Wits appraisal of 2 mm or more.
  • Mandibular deficiency (SNB angle less than 77°).
  • Growing patients.
  • No prior orthodontic intervention.
  • The vertical skeletal classification shows a horizontal or neutral growth pattern.
  • Overjet ≥ 8mm.

Exclusion criteria

  • Developmental abnormalities with atypical or irregular patterns of growth and maturation.
  • Any indications or manifestations, as well as any prior medical records, of Tempro-Mandibular Joint (TMJ) disorders, such as the presence of clicking, pain, limitations, or deviations.

Treatment and study plan

orthopedic appliance

Other

appliances are used to correct skeletal class II due to mandibular deficiency

aesthetic orthopedic appliance

Other

aesthetic appliances are used to correct skeletal class II due to mandibular deficiency

Primary outcomes

  1. skeletal effects

    Time frame: one year

    cephalometric linear and angular measurements

  2. dental effects

    Time frame: one year

    cephalometric linear and angular measurements

  3. soft tissue effects

    Time frame: one year

    cephalometric linear and angular measurements

Secondary outcomes

  1. root resorption

    Time frame: one year

    root resorption measured from CBCT

Other outcomes

  1. CBCT evaluation of TMJ

    Time frame: one year

    adverse effects of aesthetic functional appliance on the condylar head

Study contacts

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

khaled Ah Awad, surgon

CONTACT

[email protected]

1009297331

rana ka Abuzaid, orthodontist

CONTACT

[email protected]

1009389116

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II: Randomized Controlled Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 8, 2024
Registry last updated
Oct 21, 2024

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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