A Comparison of the Effectiveness of Two Types of Myofunctional Appliances

Not Applicable

Recruiting

• Conditions: Tooth Position Anomalies
• Interventions: Device: Myofunctional appliance

• Registration Number: NCT05371691
• Lead Sponsor: University of Baghdad

Brief 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).

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 Timeline

• Study Start: 2021-09-10
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-05-07
• Study First Posted: 2022-05-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-07-10
• Study Completion: 2024-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twin-block group	Myofunctional appliance	Twin-block appliance will be used for children who have Cl.II div.a malocclusion
Myobrace group	Myofunctional appliance	Myobrace appliance will be used for children who have Cl.II div.a malocclusion

Primary Outcome Measures

Name	Time	Method
Dentoskeletal changes	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.

Secondary Outcome Measures

Name	Time	Method
Soft tissue changes	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.
Patient satisfaction	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)

Trial Locations

Locations (2)

College of Dentistry-University of Baghdad; 🇮🇶 Baghdad, Al-Rusafa, Iraq

College of Dentisry-University of Baghdad; 🇮🇶 Baghdad, Iraq