A Comparison of the Effectiveness of Two Types of Myofunctional Appliances

November 27, 2023 updated by: Mushriq F. Abid, University of Baghdad

A Comparison of the Effectiveness of Two Types of Myofunctional Appliances: A Randomized Clinical Trial

A randomized clinical trial is set out to compare the effectiveness of two types of functional appliances in the correction of a Class II malocclusion. (Class II malocclusions are where upper front teeth bite significantly further forward in relation to lower front teeth).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: Myobrace appliance will be used while, and group two Twin-block appliances will be used. Cephalometric x-ray will be taken before starting the treatment (T1) and at the end of treatment (T2) at 9 months. The effectiveness of the two appliances will be assessed and measured comparing the difference in the cephalometric X-ray before and after treatment.

Study Type

Interventional

Enrollment (Estimated)

30

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

  • Iraq
      • Baghdad, Iraq
        • Recruiting
        • College of Dentisry-University of Baghdad
        • Contact:
          • Mushriq Abid, PhD
    • Al-Rusafa
      • Baghdad, Al-Rusafa, Iraq, 01110
        • Recruiting
        • College of Dentistry-University of Baghdad
        • Contact:
          • Mushriq Abid

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

8 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Growing children who need myofunctional appliance.
  2. Cl II div. 1 malocclusion.
  3. No previous orthodontic or orthopaedic treatments.

Exclusion Criteria:

  1. Patients with systemic involvement.
  2. Congenital malformations such as cleft lip and palate.
  3. Facial deformities.
  4. Finger sucking habit will be excluded

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
Experimental: Myobrace group
Myobrace appliance will be used for children who have Cl.II div.a malocclusion
Device: Myofunctional appliance
Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance
Experimental: Twin-block group
Twin-block appliance will be used for children who have Cl.II div.a malocclusion
Device: Myofunctional appliance
Myifunctional appliance will be used for growing patients who have Cl.II div.1 malocclusion, two types of appliances are involved myobrace and twin=block appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentoskeletal changes
Time Frame: T1 at the start of treatment and T2 at the end of treatment around 9 months
Evaluation of dentoskeletal and soft tissue changes following the treatment of growing children with myobrace and twin block appliances. Using cephalometric analysis to measure the angles including dental angles such as inter-incisal angle, in addition to skeletal angles such as SNA,SNB and ANB angles.
T1 at the start of treatment and T2 at the end of treatment around 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue changes
Time Frame: T1 at the start of treatment and T2 at the end of treatment around 9 months
2. Soft tissue changes using cephalometric radiographs including different angular measurement such as E-line and nasolabial angle (comparing the changes in the photographs at the beginning of the treatment and at the end of the treatment.
T1 at the start of treatment and T2 at the end of treatment around 9 months
Patient satisfaction
Time Frame: At the end of treatment (around 9 months)
3.Patient satisfaction with both appliances will be investigated using a questionnaire at the end of the study (around 9 months)
At the end of treatment (around 9 months)

Collaborators and Investigators

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

Sponsor

University of Baghdad

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 (Actual)

September 10, 2021

Primary Completion (Estimated)

July 10, 2024

Study Completion (Estimated)

August 10, 2024

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

May 7, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 387421

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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