Skeletal Open BiteAOB-Mx_INT-MSNCT07117006
Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial.
A study testing miniscrew- supported maxillary posterior segments' intrusion using clear aligners in people with Skeletal Open Bite and Open Bite, run by Cairo University at 1 site in Egypt.
Trial summary
Here's a 1,000-word (quarter-length) concise version of your research brief, preserving the key structure and essential details: Brief Summary: Comparative Management of Skeletal Anterior Open Bite Using Mini-Screw Supported Intrusion with Clear Aligners Versus Fixed Appliances PICO elements Population: Adults (17-25… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skeletal Open Bite, Open Bite, Maxillary Intrusion
- What is being tested?
- miniscrew- supported maxillary posterior segments' intrusion using clear aligners
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- uncompensated skeletal openbite with normal incisal show at rest and smiling
- good oral hygeine
Who cannot join
- systemic disease
- extraction or missing dentition
- root resorption in posterior teeth
- carious or fractured upper posterior teeth peridontal affected upper posterior teeth
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry, cairo university
Cairo, Cairo Governorate, 11528
About this study
Official title: Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial
Here's a 1,000-word (quarter-length) concise version of your research brief, preserving the key structure and essential details:
Brief Summary: Comparative Management of Skeletal Anterior Open Bite Using Mini-Screw Supported Intrusion with Clear Aligners Versus Fixed Appliances
PICO elements
Population: Adults (17-25 years) with uncompensated skeletal anterior open bite.
Intervention: TAD-supported intrusion with clear aligners. Comparison: TAD-supported intrusion with fixed appliances.
Outcomes:
Primary: Anterior open bite closure. Secondary: Molar intrusion, mandibular autorotation, incisor movement and quality of life.
Read the detailed description
The aim of the study is to compare the effects of mini-screw supported maxillary posterior segments' intrusion using fixed appliances versus clear aligners.
- Being tested
- miniscrew- supported maxillary posterior segments' intrusion using clear aligners
- Keywords
- Openbite, Skeletal anchorage, Fixed appliance, Aligners, Intrusion
- Medical subject headings
- Open Bite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miniscrew- supported maxillary posterior segments' intrusion using clear alignersDevice
maxillary posterior segments will be intruded with the aid of miniscrews and clear aligners
| Study group | Role | What they receive |
|---|---|---|
| comparator- fixed appliance | Active comparator | miniscrew-supported maxillary posterior segments' intrusion will be done using fixed appliances Receives: Device: miniscrew- supported maxillary posterior segments' intrusion using clear aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior open bite closure
the anterior open bite will be measured between the incisors using a digital caliper
Measured: 6 months
Secondary outcomes (2)
amount of maxillary posterior teeth intrusion
the distance between the molar tri-furcation/premolar center to the Frankfurt Horizontal plane
Measured: 6 months
Amount of mandibular posterior teeth extrusion
the distance between molar bi-furcation or premolar center to the mandibular plane
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 posted12 Aug 2025
- Study start30 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Open BiteStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Mohamed Ali Elkelany, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117006
- Sponsor's protocol ID
- CUFD-Ortho2025-001
- Acronym
- AOB-Mx_INT-MS
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07117006
- Acronym / sponsor ID
- AOB-Mx_INT-MS / CUFD-Ortho2025-001
- Keywords
- Openbite, Skeletal anchorage, Fixed appliance, Aligners, Intrusion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 12 Aug 2025 (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.
Here's a 1,000-word (quarter-length) concise version of your research brief, preserving the key structure and essential details:
Brief Summary: Comparative Management of Skeletal Anterior Open Bite Using Mini-Screw Supported Intrusion with Clear Aligners Versus Fixed Appliances
PICO elements
Population: Adults (17-25 years) with uncompensated skeletal anterior open bite.
Intervention: TAD-supported intrusion with clear aligners. Comparison: TAD-supported intrusion with fixed appliances.
Outcomes:
Primary: Anterior open bite closure. Secondary: Molar intrusion, mandibular autorotation, incisor movement and quality of life.
Detailed description
The aim of the study is to compare the effects of mini-screw supported maxillary posterior segments' intrusion using fixed appliances versus clear aligners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| comparator- fixed appliance | Active comparator | Device: miniscrew- supported maxillary posterior segments' intrusion using clear alignersminiscrew-supported maxillary posterior segments' intrusion will be done using fixed appliances |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- uncompensated skeletal openbite with normal incisal show at rest and smiling
- good oral hygeine
Key exclusion criteria (4 listed)
- systemic disease
- extraction or missing dentition
- root resorption in posterior teeth
- carious or fractured upper posterior teeth peridontal affected upper posterior teeth
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 |
|---|---|---|
| miniscrew- supported maxillary posterior segments' intrusion using clear alignersmaxillary posterior segments will be intruded with the aid of miniscrews and clear aligners | Device | comparator- fixed appliance |
Primary outcome
Anterior open bite closure
Time frame: 6 months
the anterior open bite will be measured between the incisors using a digital caliper
2 secondary outcomes
amount of maxillary posterior teeth intrusion
Time frame: 6 months
Amount of mandibular posterior teeth extrusion
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- 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.
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 miniscrew- supported maxillary posterior segments' intrusion using clear aligners in people with Skeletal Open Bite and Open Bite, run by Cairo 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 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Anterior open bite closure (time frame: 6 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 12 Aug 2025.