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

Primary Purpose

Malocclusion, Angle Class II, Division 1

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Myobrace Functional Appliance
Twin Block
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class II, Division 1 focused on measuring Airway, Myobrace, Twinblock

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ahmed MedianRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Myobrace functional Appliance

Twin Block Functional appliance

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 2, 2022
Last Updated
November 2, 2022
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05610150
Brief Title
Pharyngeal Airway Dimensions With Twinblock Versus Myobrace Appliances in Developing Skeletal Class II Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II, Division 1
Keywords
Airway, Myobrace, Twinblock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myobrace functional Appliance
Arm Type
Active Comparator
Arm Description
Thirteen patients with developing skeletal Class II malocclusion will be treated with Myobrace functional appliance for six months.
Arm Title
Twin Block Functional appliance
Arm Type
Active Comparator
Arm Description
Thirteen patients with developing skeletal Class II malocclusion will be treated with Twinblock functional appliance for six months.
Intervention Type
Device
Intervention Name(s)
Myobrace Functional Appliance
Intervention Description
An Appliance for treating growing Class II patients with mandibular deficiency
Intervention Type
Device
Intervention Name(s)
Twin Block
Intervention Description
An Appliance for treating growing Class II patients with mandibular deficiency
Primary Outcome Measure Information:
Title
SNA
Description
Angle formed between points Sella, Nasion and A point and describes anteroposterior position of the maxilla relative to the anterior cranial base.
Time Frame
Six months
Title
SNB
Description
Angle formed between points Sella, Nasion and B point and describes anteroposterior position of the mandible relative to the anterior cranial base.
Time Frame
Six months
Title
ANB
Description
Angle formed between points A, Nasion and B point indicating the skeletal relationship between the maxilla and the mandible.
Time Frame
Six months
Title
Witts appraisal
Description
The linear distance between the perpendicular projections of points A and B over the functional occlusal plane.
Time Frame
Six months
Title
FMA
Description
Angle formed between mandibular plane and Frankfort horizontal plane.
Time Frame
Six months
Title
Pharyngeal air way area measurement
Description
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.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina A Elfouly, Masters
Phone
+201283337933
Email
dina.elfouly@alexu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Median, PhD
Organizational Affiliation
Alexandria University
Official's Role
Study Director
Facility Information:
Facility Name
Ahmed Median
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Median, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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