Enrolling by invitation

3D Evaluation of Pharyngeal Airway and Facial Changes in Class II Patients with Twin Block and Myobrace

What is being tested

myobrace appliance

+ Twin block

Device

Who is being recruted

Malocclusion+1

+ Malocclusion, Angle Class II

+ Stomatognathic Diseases

From 10 to 14 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: May 2025

See protocol details

Summary

Principal SponsorUniversity of Baghdad

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 20, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to compare two different types of dental appliances, the Twin Block and the Myobrace, in patients with a specific dental alignment issue known as Skeletal Class II. The study is conducted at multiple locations, including a university and various dental centers in Iraq. The goal is to see how each appliance affects the airway and facial dimensions over six months of treatment. Understanding the differences between these appliances can help dentists decide the best treatment for improving dental alignment and potentially enhancing breathing, which can be crucial for overall health and development in patients with this condition. Participants in this study are randomly placed into one of two groups, each using one of the appliances. The Twin Block requires continuous wear, except during oral hygiene, with adjustments made as needed. The Myobrace is worn overnight and gradually increased in daytime use, accompanied by exercises to improve oral habits. Throughout the treatment, detailed measurements of the airway and facial features are taken using advanced imaging techniques like Cone Beam Computed Tomography and 3D facial scanning. This helps in evaluating changes in airway size and facial dimensions, allowing researchers to determine the effectiveness of each appliance in real-world settings.

Official TitleThree-Dimensional Evaluation of Pharyngeal Airway and Facial Dimension Changes in Skeletal Class II Patients Treated With Twin Block Versus Myobrace Appliances

NCT06976749

Principal SponsorUniversity of Baghdad

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MalocclusionMalocclusion, Angle Class IIStomatognathic DiseasesTooth Diseases

Criteria

7 inclusion criteria required to participate

Age: 10-14 years, at growth spurt phase as determined by the cervical vertebrae maturation stage (C3- C4 ) assessed by lateral cephalograms.

Skeletal relationship: skeletal class II (ANB angle > 4°) with normal maxilla (SNA angle 78°- 84°), and retrognathic mandible (SNB angle < 77 °).

Dental relationship: Moderate to severe dental class II division 1 malocclusion with overjet 6 -10 mm.

Convex facial profile.

Show More Criteria

6 exclusion criteria prevent from participating

Previous orthodontic/orthopedic treatment.

Patients with dental open bite

Patients with obvious facial asymmetry.

Patients with orofacial cleft.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

The appropriate size of Myobrace is chosen by using a special ruler to measure the distance between the distal portion of the lateral upper right incisor and the left, regardless of any crowding or diastema. The measure is based on the mesial-distal dimensions of the upper incisors, and not on their position. This distance is used to determine the correct size using a special table. Once chosen and inserted in patient's mouth, upper canines, even if not yet erupted, must be in their slots, so that the dental mildines coincided with the appliance's midline. In the first week, the patients will be instructed to gradually increase the wearing time of the appliance during the daytime. By the start of the second week, the patients will be instructed to wear the appliance achieving at least 8 hours during sleeping. By the end of the first 4 weeks, the patients will wear the appliances minimum of 1- 2 hours during the day plus the overnig

Group II

Experimental

It consists of maxillary and mandibular appliances that fit tightly against the teeth, alveolus, and adjacent supporting structures. Adams' clasps will be used bilaterally to anchor them to the first permanent molars and lower first premolars. A short passive labial bow will be added to the upper arch and ball end clasps to the interproximal areas of the lower arch for retention. The appliance will be fabricated after a symmetric protrusive bite registration using pink modeling wax sheets, in which the patients will rehearse many times before registration. The inclined bite blocks (ramps) will be at 70 which acts as a guiding mechanism for forward displacement of the mandible. The working bite will be taken with the incisors in an edge-to-edge relationship if possible and 2 to 3 mm bite opening between the central incisors. All the subjects will be instructed to wear the appliance 24 hours/day except for brushing. If further advancement

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Baghdad, College of Dentistry

Baghdad, IraqOpen University of Baghdad, College of Dentistry in Google Maps

Enrolling by invitationOne Study Center