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

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

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion, Angle Class II, Division 1
• Intervention / Treatment: Device: Myobrace Functional Appliance; Device: Twin Block

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina A Elfouly, Masters; Phone Number: +201283337933; Email: dina.elfouly@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Ahmed Median

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Myobrace functional Appliance; Thirteen patients with developing skeletal Class II malocclusion will be treated with Myobrace functional appliance for six months.	Device: Myobrace Functional Appliance; An Appliance for treating growing Class II patients with mandibular deficiency
Active Comparator: Twin Block Functional appliance; Thirteen patients with developing skeletal Class II malocclusion will be treated with Twinblock functional appliance for six months.	Device: Twin Block; An Appliance for treating growing Class II patients with mandibular deficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
ANB	Angle formed between points A, Nasion and B point indicating the skeletal relationship between the maxilla and the mandible.	Six months
Witts appraisal	The linear distance between the perpendicular projections of points A and B over the functional occlusal plane.	Six months
FMA	Angle formed between mandibular plane and Frankfort horizontal plane.	Six months
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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: Ahmed Median, PhD, Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Airway; Myobrace; Twinblock
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: 0418-03/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No