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

October 18, 2024 updated by: Mansoura University

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: twin block group
patient treated with twin block appliance
Other: orthopedic appliance
appliances are used to correct skeletal class II due to mandibular deficiency
Experimental: aesthetic functional group
patient treated with aesthetic functional appliance
Other: aesthetic orthopedic appliance
aesthetic appliances are used to correct skeletal class II due to mandibular deficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skeletal effects
Time Frame: one year
cephalometric linear and angular measurements
one year
dental effects
Time Frame: one year
cephalometric linear and angular measurements
one year
soft tissue effects
Time Frame: one year
cephalometric linear and angular measurements
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
root resorption
Time Frame: one year
root resorption measured from CBCT
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBCT evaluation of TMJ
Time Frame: one year
adverse effects of aesthetic functional appliance on the condylar head
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: rana ka Abuzaid, orthodontist, Egyption orthodontic socity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

October 6, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A04070240R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

skeletal and dental results

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

mandibular advancement

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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