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Clinical Trials/NCT05371691
NCT05371691
Recruiting
N/A

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

University of Baghdad2 sites in 1 country30 target enrollmentSeptember 10, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tooth Position Anomalies
Sponsor
University of Baghdad
Enrollment
30
Locations
2
Primary Endpoint
Dentoskeletal changes
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2021
End Date
August 10, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mushriq F. Abid

Professor

University of Baghdad

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Soft tissue changes(T1 at the start of treatment and T2 at the end of treatment around 9 months)
  • Patient satisfaction(At the end of treatment (around 9 months))

Study Sites (2)

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