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Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion

Primary Purpose

Effect of PowerScope Appliance in Treatment of Patients With Class 3 Malocclusion

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
powerscope
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Effect of PowerScope Appliance in Treatment of Patients With Class 3 Malocclusion

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria :

  1. Mild to moderate Class III malocclusion adolescent patients with ANB (-3 - 0).
  2. All permanent teeth are erupted (3rd molar not included).
  3. An age of patients range from 14 to 18 years.
  4. Good oral and general health.
  5. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement.
  6. No previous orthodontic treatment.

Exclusion Criteria:

  1. Orthodontic cases with severe crowding of upper and lower anterior segment that require extraction treatment approach.
  2. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.

Sites / Locations

  • Ahmed Mohamed Ibrahim Sallam

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group (A): using reversed skeletally anchored PowerScope as a fixed functional appliance.

Group (B): using dentally anchored reversed PowerScope as a fixed functional appliance

Arm Description

eight patients with mild to moderate Class IΙΙ malocclusion who will be treated by pre-adjusted straight wire appliance followed by reversed skeletally anchored PowerScope as a fixed functional appliance.

eight patients with mild to moderate Class IΙΙ malocclusion who will be treated by pre-adjusted straight wire appliance followed by dentally anchored reversed PowerScope as a fixed functional appliance

Outcomes

Primary Outcome Measures

Evaluation of different dentoskeletal cephalometric parameters
amount of dentoskeletal change by cephalometric
Evaluation soft tissue parameters
amount of soft tissue change by cephalometric

Secondary Outcome Measures

Full Information

First Posted
July 17, 2022
Last Updated
July 24, 2022
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05475548
Brief Title
Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion
Official Title
Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion: A Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
the PowerScope appliance is found to be efficient for the treatment of class II malocclusion. Accordingly, it appears valuable to investigate the efficiency of skeletally anchored powerScope in the treatment of class III malocclusion
Detailed Description
The PowerScope is the latest innovation in the treatment of Class II malocclusion which is a direct derivative of the Herbst Type II appliance. Dr. Andy Hayes worked in conjunction with American Orthodontics to develop PowerScope in 2016. This appliance supports intermaxillary wire-to-wire installation via a nut and hexagonal screw. A ball and socket joint is used to maximize lateral movement while improving patient comfort. The appliance is made up of a telescopic mechanism made up of an inner shaft/push rod, middle and outer tubing, and a spacer between the middle and outer tubing. A nickel-titanium (NiTi) spring provides a constant 260 g force. According to the present knowledge no studies regarding treatment outcomes of comprehensive fixed appliance treatment combined with the PowerScope in Class ΙII patients have been reported. The introduction of temporary anchorage devices (TADs) has made it possible to achieve absolute anchorage control in daily clinical orthodontic practice when used in conjunction with fixed functional appliances. However, it appears that there is no evidence in the literature supporting the clinical effectiveness of miniscrew- anchored fixed functional appliances for the treatment of Class III malocclusion. According to the current available literature, the PowerScope appliance is found to be efficient for the treatment of class II malocclusion. Accordingly, it appears valuable to investigate the efficiency of skeletally anchored powerScope in the treatment of class III malocclusion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of PowerScope Appliance in Treatment of Patients With Class 3 Malocclusion

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (A): using reversed skeletally anchored PowerScope as a fixed functional appliance.
Arm Type
Active Comparator
Arm Description
eight patients with mild to moderate Class IΙΙ malocclusion who will be treated by pre-adjusted straight wire appliance followed by reversed skeletally anchored PowerScope as a fixed functional appliance.
Arm Title
Group (B): using dentally anchored reversed PowerScope as a fixed functional appliance
Arm Type
Active Comparator
Arm Description
eight patients with mild to moderate Class IΙΙ malocclusion who will be treated by pre-adjusted straight wire appliance followed by dentally anchored reversed PowerScope as a fixed functional appliance
Intervention Type
Device
Intervention Name(s)
powerscope
Intervention Description
The PowerScope is the latest innovation in the treatment of Class II malocclusion which is a direct derivative of the Herbst Type II appliance. Dr. Andy Hayes worked in conjunction with American Orthodontics to develop PowerScope in 2016. This appliance supports intermaxillary wire-to-wire installation via a nut and hexagonal screw. A ball and socket joint is used to maximize lateral movement while improving patient comfort. The appliance is made up of a telescopic mechanism made up of an inner shaft/push rod, middle and outer tubing, and a spacer between the middle and outer tubing. A nickel-titanium (NiTi) spring provides a constant 260 g force. According to the present knowledge no studies regarding treatment outcomes of comprehensive fixed appliance treatment combined with the PowerScope in Class ΙII patients have been reported
Primary Outcome Measure Information:
Title
Evaluation of different dentoskeletal cephalometric parameters
Description
amount of dentoskeletal change by cephalometric
Time Frame
1.5 years
Title
Evaluation soft tissue parameters
Description
amount of soft tissue change by cephalometric
Time Frame
1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria : Mild to moderate Class III malocclusion adolescent patients with ANB (-3 - 0). All permanent teeth are erupted (3rd molar not included). An age of patients range from 14 to 18 years. Good oral and general health. No systemic disease or regular medication that could interfere and/or affect orthodontic teeth movement. No previous orthodontic treatment. Exclusion Criteria: Orthodontic cases with severe crowding of upper and lower anterior segment that require extraction treatment approach. Patients with a blocked-out tooth that will not allow for placement of the bracket at the initial bonding appointment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Sallam, student
Organizational Affiliation
Al-Azhar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Mohamed Ibrahim Sallam
City
Cairo
ZIP/Postal Code
20
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12923506
Citation
O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of treatment for Class II malocclusion with the Herbst or twin-block appliances: a randomized, controlled trial. Am J Orthod Dentofacial Orthop. 2003 Aug;124(2):128-37. doi: 10.1016/s0889-5406(03)00345-7.
Results Reference
background
PubMed Identifier
28885034
Citation
Eissa O, El-Shennawy M, Gaballah S, El-Meehy G, El Bialy T. Treatment outcomes of Class II malocclusion cases treated with miniscrew-anchored Forsus Fatigue Resistant Device: A randomized controlled trial. Angle Orthod. 2017 Nov;87(6):824-833. doi: 10.2319/032717-214.1. Epub 2017 Sep 8.
Results Reference
background

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Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion

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