Back to results3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion (Powerscope app)
Primary Purpose
Class II Malocclusion, Division 1
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Powerscope group
Sponsored by
About this trial
This is an interventional treatment trial for Class II Malocclusion, Division 1
Eligibility Criteria
Inclusion Criteria:
- Healthy post pubertal female patients of age range 14 to 16 years old, manifesting features of post pubertal cervical vertebrae maturational stages 4, 5 and 6 (deceleration, maturation, and completion).
- Skeletal class 2 malocclusion of ANB angle greater than 4° with retrognathic mandible.
- Class II division 1 malocclusion with at least an end-on Class II molar relationship.
- Presence of all permanent dentition excluding third molars.
- Good oral hygiene.
Exclusion Criteria:
- History of previous orthodontic treatment.
- Any systemic disease that could affect the orthodontic treatment.
- Patients with periodontal diseases.
- Patients with temporomandibular disorders.
Sites / Locations
- Al-Azhar university, Faculty of oral and dental medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Powerscope group
Arm Description
Class II patients which will receive treatment using Powerscope appliance
Outcomes
Primary Outcome Measures
The Condylar head volumetric changes
The change in Condylar head volume before and after usage of Powerscope appliance
Secondary Outcome Measures
Mandibular length
The change in the length of the mandible
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04972084
Brief Title
3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion
Acronym
Powerscope app
Official Title
Three-dimensional Evaluation of the Efficacy of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion: A Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
September 5, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is aiming to evaluate the efficacy of Powerscope appliance in treatment of skeletal Class 2 malocclusion by three-dimensional image. Powerscope appliance is a hybrid fixed functional appliance used for treatment of Class II malocclusion with a retruded mandible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Malocclusion, Division 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Powerscope group
Arm Type
Experimental
Arm Description
Class II patients which will receive treatment using Powerscope appliance
Intervention Type
Device
Intervention Name(s)
Powerscope group
Intervention Description
Treatment of Class II malocclusions using Powerscope appliance
Primary Outcome Measure Information:
Title
The Condylar head volumetric changes
Description
The change in Condylar head volume before and after usage of Powerscope appliance
Time Frame
six months
Secondary Outcome Measure Information:
Title
Mandibular length
Description
The change in the length of the mandible
Time Frame
six months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only females are enrolled in the study
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy post pubertal female patients of age range 14 to 16 years old, manifesting features of post pubertal cervical vertebrae maturational stages 4, 5 and 6 (deceleration, maturation, and completion).
Skeletal class 2 malocclusion of ANB angle greater than 4° with retrognathic mandible.
Class II division 1 malocclusion with at least an end-on Class II molar relationship.
Presence of all permanent dentition excluding third molars.
Good oral hygiene.
Exclusion Criteria:
History of previous orthodontic treatment.
Any systemic disease that could affect the orthodontic treatment.
Patients with periodontal diseases.
Patients with temporomandibular disorders.
Facility Information:
Facility Name
Al-Azhar university, Faculty of oral and dental medicine
City
Cairo
State/Province
Naser City
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
A year
Learn more about this trial
3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion
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