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

NCT05610150 | Completed

• 1 other identifier: 0418-03/2022
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion, Angle Class II, Division 1

Keywords

Airway; Myobrace; Twinblock

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Myobrace functional Appliance

ACTIVE COMPARATOR

Thirteen patients with developing skeletal Class II malocclusion will be treated with Myobrace functional appliance for six months.

Device: Myobrace Functional Appliance

Twin Block Functional appliance

ACTIVE COMPARATOR

Thirteen patients with developing skeletal Class II malocclusion will be treated with Twinblock functional appliance for six months.

Device: Twin Block

Interventions

Myobrace Functional Appliance DEVICE

An Appliance for treating growing Class II patients with mandibular deficiency

Myobrace functional Appliance

Twin Block DEVICE

An Appliance for treating growing Class II patients with mandibular deficiency

Twin Block Functional appliance

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children
• 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)

You may not qualify if:

• Previous Orthodontic treatment
• Previous extractions
• mandibular shifts
• Severe Crowding
• Anterior open bite
• Any perioral habits

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Ahmed Median

Alexandria, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Median, PhD

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: April 1, 2022
• Primary Completion: April 15, 2023
• Study Completion: April 30, 2023
• Last Updated: February 1, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)