Class II Malocclusion, Division 1Powerscope appNCT04972084
3D Evaluation of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion
A study testing Powerscope group in people with Class II Malocclusion, Division 1, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion, Division 1
- What is being tested?
- Powerscope group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2020to 6 Sep 2021
- 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 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
- Skeletal class 2 malocclusion of ANB angle greater than 4° with retrognathic mandible.
- Class II division 1 malocclusion with at least an end-on Class II molar relationship.
- Presence of all permanent dentition excluding third molars.
- Good oral hygiene.
Who cannot join
- History of previous orthodontic treatment.
- Any systemic disease that could affect the orthodontic treatment.
- Patients with periodontal diseases.
- Patients with temporomandibular disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Al-Azhar university, Faculty of oral and dental medicine
Cairo, Naser City
About this study
Official title: 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.
- Conditions
- Class II Malocclusion, Division 1
- Being tested
- Powerscope group
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powerscope groupDevice
Treatment of Class II malocclusions using Powerscope appliance
| Study group | Role | What they receive |
|---|---|---|
| Powerscope group | Experimental | Class II patients which will receive treatment using Powerscope appliance Receives: Device: Powerscope group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Condylar head volumetric changes
The change in Condylar head volume before and after usage of Powerscope appliance
Measured: six months
Secondary outcomes (1)
Mandibular length
The change in the length of the mandible
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start15 Jul 2020
- Primary completion5 Sep 2021
- Study completion6 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Malocclusion, Division 1Studies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Essam Mohamed El-Hossainy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972084
- Sponsor's protocol ID
- 3D Powerscope Class II ttt
- Acronym
- Powerscope app
- Status last verified
- Sep 2021
- First submitted
- 1 Jul 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Evaluation of the Efficacy of Powerscope Appliance in Treatment of Skeletal Class 2 Malocclusion: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04972084
- Acronym / sponsor ID
- Powerscope app / 3D Powerscope Class II ttt
- Conditions
- Class II Malocclusion, Division 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 22 Jul 2021 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Powerscope group | Experimental | Device: Powerscope groupClass II patients which will receive treatment using Powerscope appliance |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
- Skeletal class 2 malocclusion of ANB angle greater than 4° with retrognathic mandible.
- Class II division 1 malocclusion with at least an end-on Class II molar relationship.
- Presence of all permanent dentition excluding third molars.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- History of previous orthodontic treatment.
- Any systemic disease that could affect the orthodontic treatment.
- Patients with periodontal diseases.
- Patients with temporomandibular disorders.
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 |
|---|---|---|
| Powerscope groupTreatment of Class II malocclusions using Powerscope appliance | Device | Powerscope group |
Primary outcome
The Condylar head volumetric changes
Time frame: six months
The change in Condylar head volume before and after usage of Powerscope appliance
1 secondary outcome
Mandibular length
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 group in people with Class II Malocclusion, Division 1, 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Condylar head volumetric changes (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2021.