Class II MalocclusionNCT06511219
Maxillary Segmental Distalization Using Digitally Printed Appliances
A study testing maxillary segmental distalization in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial summary
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- maxillary segmental distalization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2024to 12 Apr 2026
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients age (13- 18) years.
- Full permanent dentition except third molar.
- Class II malocclusion with at least an end-on Class II molar relationship bilaterally.
- normal or short lower facial height.
Who cannot join
- Systemic conditions that may interfere with the treatment.
- Bad habits that might jeopardize the appliance.
- Transverse discrepancy.
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
Marwa A Tawfik, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Dentistry
Al Mansurah, 35516
mansoura university
About this study
Official title: Evaluation of Maxillary Segmental Distalization Using Infra Zygomatic Versus Palatal Digitally Printed Skeletal Anchored Appliances
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.
Read the detailed description
Ethical approval All selected patients will be informed about the aims and characteristics of the study, the potential risks and benefits and the option of withdrawing from it whenever they desire. Then all patients will sign the informed consent document. All patients will be informed about the results after finishing. All selected patients' personal data and details will be held and handled confidentially and privately in the orthodontic department, faculty of dentistry, Mansoura university.
Trial design
Patients will be randomly allocated into two groups as follow:
- First group: Buccal segmental digitally printed maxillary distalizer (infrazygomatic mini-implant IZC).
- Second group: palatal segmental digitally printed maxillary distalizer.
The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews.
The distalizer will be composed of digitally printed metal shell which is bonded to the palatal surface of the whole posterior segment.
Transpalatal arm will connect the two sides to avoid buccal tipping during distalization.
The distalization will be done by placing chain elastics from the miniscrews to the hook present in the mesial aspect of the appliance.
The palatal segmental distalizer will take anchorage from miniscrews placed in the anterior palate.
The appliance will be bonded to the palatal surface of the posterior segment and containing two anterior and two posterior hooks.
The distalization will be performed by using chain elastics between the anterior and posterior hooks.
Force: 300-350 gram per side which will be measured using force gauge.
A follow-up session will be scheduled every 3weeks, and the appliance will be removed in both groups after the patient reach a Class I relationship. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization.
- Conditions
- Class II Malocclusion
- Being tested
- maxillary segmental distalization
- Keywords
- class II maloccluusion, miniscrew
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary segmental distalizationDevice
maxillary segmental distalization using skeletal anchored digitally printed appliances
| Study group | Role | What they receive |
|---|---|---|
| maxillary segmental distalization using infrazygomatic digitally printed appliances | Active comparator | maxillary segmental distalization using infrazygomatic digitally printed appliances Receives: Device: maxillary segmental distalization |
| maxillary segmental distalization using palatal digitally printed appliances | Active comparator | maxillary segmental distalization using palatal digitally printed appliances Receives: Device: maxillary segmental distalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.
this study includes 40 patients with class II molar and canine relation the study aimes to investigate the effect of the skeletal anchored digitally printed distalizers on the distal movement of the maxillary posterior segment in millimeters
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start12 Apr 2024
- Primary completion12 Jan 2026 (estimated)
- Study completion12 Apr 2026 (estimated)
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.
- 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
- The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews (IZC). the palatal distalizer take anchorage from palate
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Elabd, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511219
- Sponsor's protocol ID
- phd
- Status last verified
- Jul 2024
- First submitted
- 21 Jun 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maxillary Segmental Distalization Using Infra Zygomatic Versus Palatal Digitally Printed Skeletal Anchored Appliances
- ClinicalTrials.gov ID
- NCT06511219
- Acronym / sponsor ID
- phd
- Conditions
- Class II Malocclusion
- Keywords
- class II maloccluusion, miniscrew
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 12 Jan 2026 (estimated)
- Study completion
- 12 Apr 2026 (estimated)
- First posted
- 19 Jul 2024 (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.
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.
Detailed description
Ethical approval All selected patients will be informed about the aims and characteristics of the study, the potential risks and benefits and the option of withdrawing from it whenever they desire. Then all patients will sign the informed consent document. All patients will be informed about the results after finishing. All selected patients' personal data and details will be held and handled confidentially and privately in the orthodontic department, faculty of dentistry, Mansoura university.
Trial design
Patients will be randomly allocated into two groups as follow:
- First group: Buccal segmental digitally printed maxillary distalizer (infrazygomatic mini-implant IZC).
- Second group: palatal segmental digitally printed maxillary distalizer.
The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews.
The distalizer will be composed of digitally printed metal shell which is bonded to the palatal surface of the whole posterior segment.
Transpalatal arm will connect the two sides to avoid buccal tipping during distalization.
The distalization will be done by placing chain elastics from the miniscrews to the hook present in the mesial aspect of the appliance.
The palatal segmental distalizer will take anchorage from miniscrews placed in the anterior palate.
The appliance will be bonded to the palatal surface of the posterior segment and containing two anterior and two posterior hooks.
The distalization will be performed by using chain elastics between the anterior and posterior hooks.
Force: 300-350 gram per side which will be measured using force gauge.
A follow-up session will be scheduled every 3weeks, and the appliance will be removed in both groups after the patient reach a Class I relationship. For each patient, two lateral cephalograms will be obtained: one preoperatively and another after completion of distalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The buccal segmental distalizer will take the anchorage from infrazygomatic miniscrews (IZC). the palatal distalizer take anchorage from palate
| Arm | Type | Receives |
|---|---|---|
| maxillary segmental distalization using infrazygomatic digitally printed appliances | Active comparator | Device: maxillary segmental distalizationmaxillary segmental distalization using infrazygomatic digitally printed appliances |
| maxillary segmental distalization using palatal digitally printed appliances | Active comparator | Device: maxillary segmental distalizationmaxillary segmental distalization using palatal digitally printed appliances |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients age (13- 18) years.
- Full permanent dentition except third molar.
- Class II malocclusion with at least an end-on Class II molar relationship bilaterally.
- normal or short lower facial height.
Key exclusion criteria (4 listed)
- Systemic conditions that may interfere with the treatment.
- Bad habits that might jeopardize the appliance.
- Transverse discrepancy.
- Previous 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 |
|---|---|---|
| maxillary segmental distalizationmaxillary segmental distalization using skeletal anchored digitally printed appliances | Device | maxillary segmental distalization using infrazygomatic digitally printed appliances, maxillary segmental distalization using palatal digitally printed appliances |
Primary outcome
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.
Time frame: 10 months
this study includes 40 patients with class II molar and canine relation the study aimes to investigate the effect of the skeletal anchored digitally printed distalizers on the distal movement of the maxillary posterior segment in millimeters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
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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.
Marwa A Tawfik, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary segmental distalization in people with Class II Malocclusion, run by Mansoura 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 4 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: status not confirmed, as of the sponsor's last update on 30 May 2025. 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?
Contact Asmaa A Elabd, teatching assistant (01068836018, asmaaelabd55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances. (time frame: 10 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 30 May 2025.