3D Evaluation of Powerscope Appliance in Treatment of Ske... | NCT04972084

Studies
3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion

NCT04972084

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Sep 14, 2021Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Class II Malocclusion, Division 1

Interventions

Powerscope group

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2020Actual

Primary Completion Date

Sep 5, 2021Actual

Completion Date

Sep 6, 2021Actual

First Submitted Date

Jul 1, 2021

First Submission Date that Met QC Criteria

Jul 12, 2021

First Posted Date

Jul 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2021

Last Update Posted Date

Sep 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hany Essam Mohamed El-Hossainy, Master's degree candidate, Orthodontic department, Al-Azhar University, Al-Azhar UniversityPrincipal Investigator

Lead Sponsor

Al-Azhar UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Powerscope group	Experimental	Class II patients which will receive treatment using Powerscope appliance	Device: Powerscope group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Powerscope group	Device	Treatment of Class II malocclusions using Powerscope appliance	Powerscope group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Condylar head volumetric changes	The change in Condylar head volume before and after usage of Powerscope appliance	six months

Secondary Outcomes

Measure	Description	Time Frame
Mandibular length	The change in the length of the mandible	six months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Only females are enrolled in the study

Minimum Age

14 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-Azhar university, Faculty of oral and dental medicine		Cairo	Naser City		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

A year

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008312	Malocclusion, Angle Class II

Ancestor Terms

ID	Term
D008310	Malocclusion
D014076	Tooth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided