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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 20
- Ahmed Mohamed Ibrahim Sallam
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
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.
|
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
|
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
Time Frame: 1.5 years
|
amount of dentoskeletal change by cephalometric
|
1.5 years
|
|
Evaluation soft tissue parameters
Time Frame: 1.5 years
|
amount of soft tissue change by cephalometric
|
1.5 years
|
Collaborators and Investigators
Sponsor
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)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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