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

Not Applicable

Completed

• Conditions: Malocclusion, Angle Class II, Division 1
• Interventions: Device: Myobrace Functional Appliance; Device: Twin Block

• Registration Number: NCT05610150
• Lead Sponsor: Alexandria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2022-10
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-09
• Primary Completion: 2023-04-15
• Study Completion: 2023-04-30
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myobrace functional Appliance	Myobrace Functional Appliance	Thirteen patients with developing skeletal Class II malocclusion will be treated with Myobrace functional appliance for six months.
Twin Block Functional appliance	Twin Block	Thirteen patients with developing skeletal Class II malocclusion will be treated with Twinblock functional appliance for six months.

Primary Outcome Measures

Name	Time	Method
SNA	Six months	Angle formed between points Sella, Nasion and A point and describes anteroposterior position of the maxilla relative to the anterior cranial base.
SNB	Six months	Angle formed between points Sella, Nasion and B point and describes anteroposterior position of the mandible relative to the anterior cranial base.
Witts appraisal	Six months	The linear distance between the perpendicular projections of points A and B over the functional occlusal plane.
FMA	Six months	Angle formed between mandibular plane and Frankfort horizontal plane.
ANB	Six months	Angle formed between points A, Nasion and B point indicating the skeletal relationship between the maxilla and the mandible.
Pharyngeal air way area measurement	Six months	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.

Trial Locations

Locations (1)

Ahmed Median; 🇪🇬 Alexandria, Egypt