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Clinical Trials/NCT05610150
NCT05610150
Completed
Not Applicable

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

Alexandria University1 site in 1 country26 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malocclusion, Angle Class II, Division 1
Sponsor
Alexandria University
Enrollment
26
Locations
1
Primary Endpoint
SNA
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
April 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Witts appraisal

Time Frame: Six months

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

FMA

Time Frame: Six months

Angle formed between mandibular plane and Frankfort horizontal plane.

ANB

Time Frame: 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

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.

Study Sites (1)

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