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Completed

NCT Number: NCT05610150

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

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.

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Key information

Conditions

Malocclusion, Angle Class II, Division 1 Malocclusion Malocclusion, Angle Class II Stomatognathic Diseases Tooth Diseases

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Median

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myobrace Functional Appliance

Device

An Appliance for treating growing Class II patients with mandibular deficiency

Twin Block

Device

An Appliance for treating growing Class II patients with mandibular deficiency

Primary outcomes

  1. SNA

    Time frame: Six months

    Angle formed between points Sella, Nasion and A point and describes anteroposterior position of the maxilla relative to the anterior cranial base.

  2. SNB

    Time frame: Six months

    Angle formed between points Sella, Nasion and B point and describes anteroposterior position of the mandible relative to the anterior cranial base.

  3. ANB

    Time frame: Six months

    Angle formed between points A, Nasion and B point indicating the skeletal relationship between the maxilla and the mandible.

  4. Witts appraisal

    Time frame: Six months

    The linear distance between the perpendicular projections of points A and B over the functional occlusal plane.

  5. FMA

    Time frame: Six months

    Angle formed between mandibular plane and Frankfort horizontal plane.

  6. Pharyngeal air way area measurement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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