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Not yet recruiting NCT06631235

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

No phase Interventional Skeletal Malocclusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: orthopedic appliance, aesthetic orthopedic appliance.
Who it may be relevant to
Registry conditions: Skeletal Malocclusion. Basic parameters: 8 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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)

Detailed description

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 .

Interventions

  • Other orthopedic appliance
    appliances are used to correct skeletal class II due to mandibular deficiency
  • Other aesthetic orthopedic appliance
    aesthetic appliances are used to correct skeletal class II due to mandibular deficiency

Primary outcome measures

  • skeletal effects [Time frame: one year]
  • dental effects [Time frame: one year]
  • soft tissue effects [Time frame: one year]
Secondary outcome measures (1)
  • root resorption [Time frame: one year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry — Al Mansurah

Identifiers

NCT: NCT06631235 · A04070240R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗