3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion (Powerscope app)

Three-dimensional Evaluation of the Efficacy of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion: A Prospective Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Class II Malocclusion, Division 1
• Intervention / Treatment: Device: Powerscope group

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Naser City
    • Cairo, Naser City, Egypt
      • Al-Azhar university, Faculty of oral and dental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. 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).
2. Skeletal class 2 malocclusion of ANB angle greater than 4° with retrognathic mandible.
3. Class II division 1 malocclusion with at least an end-on Class II molar relationship.
4. Presence of all permanent dentition excluding third molars.
5. Good oral hygiene.

Exclusion Criteria:

1. History of previous orthodontic treatment.
2. Any systemic disease that could affect the orthodontic treatment.
3. Patients with periodontal diseases.
4. Patients with temporomandibular disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Powerscope group; Class II patients which will receive treatment using Powerscope appliance	Device: Powerscope group; Treatment of Class II malocclusions using Powerscope appliance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): September 5, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class II; Overbite
• Other Study ID Numbers: 3D Powerscope Class II ttt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: A year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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