NCT04972084

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 22, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

July 1, 2021

Last Update Submit

September 7, 2021

Conditions

Class II Malocclusion, Division 1

Outcome Measures

Primary Outcomes (1)

  • The Condylar head volumetric changes

    The change in Condylar head volume before and after usage of Powerscope appliance

    six months

Secondary Outcomes (1)

  • Mandibular length

    six months

Study Arms (1)

Powerscope group

EXPERIMENTAL

Class II patients which will receive treatment using Powerscope appliance

Device: Powerscope group

Interventions

Powerscope groupDEVICE

Treatment of Class II malocclusions using Powerscope appliance

Powerscope group

Eligibility Criteria

Age14 Years - 16 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females are enrolled in the study
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • History of previous orthodontic treatment.
  • Any systemic disease that could affect the orthodontic treatment.
  • Patients with periodontal diseases.
  • Patients with temporomandibular disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar university, Faculty of oral and dental medicine

Cairo, Naser City, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's degree candidate, Orthodontic department, Al-Azhar University

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 22, 2021

Study Start

July 15, 2020

Primary Completion

September 5, 2021

Study Completion

September 6, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
A year

Locations

EG(1)