Effect of PowerScope Appliance in Treatment of Patients With Class 3 MalocclusionNCT05475548
Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion
A study testing powerscope in people with Effect of PowerScope Appliance in Treatment of Patients With Class 3 Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of PowerScope Appliance in Treatment of Patients With Class 3 Malocclusion
- What is being tested?
- powerscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- powerscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
powerscopeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Group (A): using reversed skeletally anchored PowerScope as a fixed functional appliance. | Active comparator | 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. Receives: Device: powerscope |
| Group (B): using dentally anchored reversed PowerScope as a fixed functional appliance | Active comparator | 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 Receives: Device: powerscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of different dentoskeletal cephalometric parameters
amount of dentoskeletal change by cephalometric
Measured: 1.5 years
Evaluation soft tissue parameters
amount of soft tissue change by cephalometric
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effect of PowerScope Appliance in Treatment of Patients With Class 3 MalocclusionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ibrahim Sallam, Al-Azhar University
- Investigators
- Ahmed Mohamed Sallam, student, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475548
- Sponsor's protocol ID
- 786/2231
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12923506Eissa 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.
PubMed 28885034
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Skeletally Anchored Reversed PowerScope Appliance in Orthodontic Treatment of Patients With Class III Malocclusion: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT05475548
- Acronym / sponsor ID
- 786/2231
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A): using reversed skeletally anchored PowerScope as a fixed functional appliance. | Active comparator | Device: powerscopeeight 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. |
| Group (B): using dentally anchored reversed PowerScope as a fixed functional appliance | Active comparator | Device: powerscopeeight 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 |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| powerscopeThe 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 | Device | Group (A): using reversed skeletally anchored PowerScope as a fixed functional appliance., Group (B): using dentally anchored reversed PowerScope as a fixed functional appliance |
Primary outcome
Evaluation of different dentoskeletal cephalometric parameters
Time frame: 1.5 years
amount of dentoskeletal change by cephalometric
Evaluation soft tissue parameters
Time frame: 1.5 years
amount of soft tissue change by cephalometric
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Background: PubMed 12923506O'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.
- Background: PubMed 28885034Eissa 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mohamed Sallam, student principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing powerscope in people with Effect of PowerScope Appliance in Treatment of Patients With Class 3 Malocclusion, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of different dentoskeletal cephalometric parameters (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05475548, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.