A Comparison of the Effectiveness of Two Types of Myofunctional Appliances

Tooth Position Anomalies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371691
• Other study ID #: 387421
• Status: Recruiting
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: August 10, 2024

Study information

• Verified date: November 2023
• Source: University of Baghdad
• Contact: Mushriq Abid
• Phone: 7718800706
• Email: mushriq.abid[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 10, 2024
• Est. primary completion date: July 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Position Anomalies

Intervention

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

Locations

Country	Name	City	State
Iraq	College of Dentisry-University of Baghdad	Baghdad
Iraq	College of Dentistry-University of Baghdad	Baghdad	Al-Rusafa

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dentoskeletal changes	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	Soft tissue changes	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
Secondary	Patient satisfaction	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)