Pharyngeal Airway Dimensions With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients

Malocclusion, Angle Class II, Division 1 Clinical Trial

Official title:

Cephalometric Changes in Pharyngeal Airway Dimensions After Functional Treatment With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610150
• Other study ID #: 0418-03/2022
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the pharyngeal airway changes after treatment with Myobrace and after treatment with Twinblock in developing skeletal Class II patients.

The main question it aims to answer is: Is the efficacy of the twin-block Vs Myobrace appliances in the improvement of pharyngeal airway dimensions in adolescents having skeletal Class II malocclusion with retrognathic mandible utilizing sagittal pharyngeal airway area measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 30, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

• Healthy children

• 9-12 Years

• Skeletal Class II with mandibular defeciency and normal maxillary growth depending on clinical diagnosis and confirmed with lateral cephalometric x-reay readings ( ANB angle >4 and SNA angle <78)

Exclusion Criteria:

• Previous Orthodontic treatment

• Previous extractions

• mandibular shifts

• Severe Crowding

• Anterior open bite

• Any perioral habits

Related Conditions & MeSH terms

• Malocclusion
• Malocclusion, Angle Class II
• Malocclusion, Angle Class II, Division 1

Intervention

Device:
• Myobrace Functional Appliance
An Appliance for treating growing Class II patients with mandibular deficiency
• Twin Block
An Appliance for treating growing Class II patients with mandibular deficiency

Locations

Country	Name	City	State
Egypt	Ahmed Median	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNA	Angle formed between points Sella, Nasion and A point and describes anteroposterior position of the maxilla relative to the anterior cranial base.	Six months
Primary	SNB	Angle formed between points Sella, Nasion and B point and describes anteroposterior position of the mandible relative to the anterior cranial base.	Six months
Primary	ANB	Angle formed between points A, Nasion and B point indicating the skeletal relationship between the maxilla and the mandible.	Six months
Primary	Witts appraisal	The linear distance between the perpendicular projections of points A and B over the functional occlusal plane.	Six months
Primary	FMA	Angle formed between mandibular plane and Frankfort horizontal plane.	Six months
Primary	Pharyngeal air way area measurement	The upper border of Naso Pharyngeal air way area will be delineated by a line extending from the harmonium (H) to the posterior nasal spine. The lower extent of the NPAA will be traced by marking a line at the tip of the soft palate parallel to the Frankfort horizontal (FH) plane extending to the posterior wall of the pharynx. The OPAA and LPAA are differentiated by a line drawn at the level of the tip of epiglottis parallel to the FH plane to the posterior wall of the pharynx. The lower border of the LPAA is defined as a line drawn parallel to FH plane and passing through the anteroinferior most point (C5AI) of the fifth cervical vertebra. Area will be measured.	Six months