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

Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion: A Prospective Clinical Study

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Effect of PowerScope Appliance in Treatment of Patients With Class 3 Malocclusion
• Intervention / Treatment: Device: powerscope

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 20
    • Ahmed Mohamed Ibrahim Sallam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (A): using 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 reversed skeletally anchored PowerScope as a fixed functional appliance.	Device: powerscope; 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
Active Comparator: Group (B): using dentally anchored reversed 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	Device: powerscope; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of different dentoskeletal cephalometric parameters	amount of dentoskeletal change by cephalometric	1.5 years
Evaluation soft tissue parameters	amount of soft tissue change by cephalometric	1.5 years

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Ahmed Mohamed Sallam, student, Al-Azhar University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Tooth Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Malocclusion; Prognathism; Malocclusion, Angle Class III
• Other Study ID Numbers: 786/2231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No