Class II MalocclusionNCT05555719
Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study
A study testing Mandibular Protraction Appliance and PowerScope Appliance in people with Class II Malocclusion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- Mandibular Protraction Appliance and PowerScope Appliance
- 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
- 1 Nov 2019to 1 Aug 2022
- 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Skeletal and dental class II malocclusion with mandibular retrognathia, SNB>= 4.
- Patients in cervical vertebral maturation index 3 -5.
- Age ranged from 13-16 years.
- Overjet ≥ 5 mm.
- Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars).
- Good oral hygiene and general health.
- No previous orthodontic treatment or jaw's surgery.
Who cannot join
- Class I skeletal malocclusion
- periodontally compromised patient
- patients have systemic diseases interfering with orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases
Read the detailed description
Comparison between two types of fixed functional appliances, the first one is the Mandibular Protraction Appliances, while the second one was the PowerScope Appliance.
the treatment duration was 6 months the patients age was considered according to Baccetti et al, CVMI 3,4
- Conditions
- Class II Malocclusion
- Being tested
- Mandibular Protraction Appliance, PowerScope Appliance
- Keywords
- PowerScope, Mandibular Protraction Appliance
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Protraction ApplianceDevice
Mandibular Protraction Appliance was installed on fixed orthodontic appliance
PowerScope ApplianceDevice
PowerScope Appliance was installed on fixed orthodontic appliance
| Study group | Role | What they receive |
|---|---|---|
| Mandibular Protraction Appliance | Experimental | the first group that received Mandibular Protraction Appliance Receives: Device: Mandibular Protraction Appliance |
| PowerScope Appliances | Experimental | the first group that received PowerScope Appliances Receives: Device: PowerScope Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
SNA angle (on Cephalometric radiograph)
Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line)
Measured: 6 months
SNB angle (on Cephalometric radiograph)
Anteroposterior postition of mandible in relation to the anterior cranial base (SN line)
Measured: 6 months
ANB angle (on Cephalometric radiograph)
The relationaship between maxilla and mandible
Measured: 6 months
Effective mandibular length (mm) (on Cephalometric radiograph)
the length of the mandible (change in length before and after treatment)
Measured: 6 months
Mandibular plane angle (on Cephalometric radiograph)
the angle between inferior border of the mandible (Go Me) and the anterior cranial base (SN line)
Measured: 6 months
Maxillary incisors inclination (angle) (on Cephalometric radiograph)
The change of maxillary incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)
Measured: 6 months
Mandibular incisors inclination (angle) (on Cephalometric radiograph)
The change of mandibular incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)
Measured: 6 months
Secondary outcomes (2)
Upper lip retrusion (mm) (on Cephalometric radiograph)
the amount of upper lip retrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)
Measured: 6 months
Lower lip protrusion (on Cephalometric radiograph)
the amount of lower lip protrusion in millimeter in relation to E line (line extended between pronasale and soft tissue pogonion points)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start1 Nov 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 treatment groups, both have class II malocclusion
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abo bakr fouad, Al-Azhar University
- Investigators
- Abubakr M Fouad, Principal investigator, Al-azhar university, Cairo - Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555719
- Sponsor's protocol ID
- 346/1137/16/10/19
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT05555719
- Acronym / sponsor ID
- 346/1137/16/10/19
- Conditions
- Class II Malocclusion
- Keywords
- PowerScope, Mandibular Protraction Appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 27 Sep 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.
Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases
Detailed description
Comparison between two types of fixed functional appliances, the first one is the Mandibular Protraction Appliances, while the second one was the PowerScope Appliance.
the treatment duration was 6 months the patients age was considered according to Baccetti et al, CVMI 3,4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 treatment groups, both have class II malocclusion
| Arm | Type | Receives |
|---|---|---|
| Mandibular Protraction Appliance | Experimental | Device: Mandibular Protraction Appliancethe first group that received Mandibular Protraction Appliance |
| PowerScope Appliances | Experimental | Device: PowerScope Appliancethe first group that received PowerScope Appliances |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Skeletal and dental class II malocclusion with mandibular retrognathia, SNB>= 4.
- Patients in cervical vertebral maturation index 3 -5.
- Age ranged from 13-16 years.
- Overjet ≥ 5 mm.
- Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars).
Key exclusion criteria (3 listed)
- Class I skeletal malocclusion
- periodontally compromised patient
- patients have systemic diseases interfering with orthodontic treatment
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 |
|---|---|---|
| Mandibular Protraction ApplianceMandibular Protraction Appliance was installed on fixed orthodontic appliance | Device | Mandibular Protraction Appliance |
| PowerScope AppliancePowerScope Appliance was installed on fixed orthodontic appliance | Device | PowerScope Appliances |
Primary outcome
SNA angle (on Cephalometric radiograph)
Time frame: 6 months
Anteroposterior postition of maxilla in relation to the anterior cranial base (SN line)
SNB angle (on Cephalometric radiograph)
Time frame: 6 months
Anteroposterior postition of mandible in relation to the anterior cranial base (SN line)
ANB angle (on Cephalometric radiograph)
Time frame: 6 months
The relationaship between maxilla and mandible
Effective mandibular length (mm) (on Cephalometric radiograph)
Time frame: 6 months
the length of the mandible (change in length before and after treatment)
Mandibular plane angle (on Cephalometric radiograph)
Time frame: 6 months
the angle between inferior border of the mandible (Go Me) and the anterior cranial base (SN line)
Maxillary incisors inclination (angle) (on Cephalometric radiograph)
Time frame: 6 months
The change of maxillary incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)
Mandibular incisors inclination (angle) (on Cephalometric radiograph)
Time frame: 6 months
The change of mandibular incisors inclination between the long axis of most protruded upper incisors and anterior cranial base (Sn line)
2 secondary outcomes
Upper lip retrusion (mm) (on Cephalometric radiograph)
Time frame: 6 months
Lower lip protrusion (on Cephalometric radiograph)
Time frame: 6 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 13 Oct 2022.
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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.
Abubakr M Fouad principal investigator
Al-azhar university, Cairo - Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Protraction Appliance and PowerScope Appliance in people with Class II 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 7 inclusion and 3 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 13 Oct 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?
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?
SNA angle (on Cephalometric radiograph) (time frame: 6 months). The study lists 7 primary outcomes in all. 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 13 Oct 2022; AzTrials last refreshed its copy on 1 Nov 2026.