ClinicalTrials.gg
Active, not recruitingNCT07117006AOB-Mx_INT-MSUpdated Aug 12, 2025

Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial.

An interventional study of miniscrew- supported maxillary posterior segments' intrusion using clear aligners in Skeletal Open Bite, Open Bite and Maxillary Intrusion, sponsored by Cairo University. Active, not recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-08-12.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as active, not recruiting.
  • Registered 7 months after the study started (first participant enrolled Dec 2024, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Skeletal Open Bite
  • Open Bite
  • Maxillary Intrusion
  • Mini-screws
  • Clear Aligner Appliance

Browse trials for

Keywords

  • Openbite
  • Skeletal anchorage
  • Fixed appliance
  • Aligners
  • Intrusion
03

In context

Open Bite

34 studies on the registry are indexed under Open Bite; 8 are open to participants now.

This study's planned enrollment of 8 is below the median of 30 across 28 interventional studies indexed under Open Bite.

Browse Open Bite studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • uncompensated skeletal openbite with normal incisal show at rest and smiling
  • good oral hygeine

Exclusion criteria

Exclusion Criteria:

  • systemic disease
  • extraction or missing dentition
  • root resorption in posterior teeth
  • carious or fractured upper posterior teeth peridontal affected upper posterior teeth
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
8 participants (estimated)

Study arms

  • Active comparator
    comparator- fixed appliance

    miniscrew-supported maxillary posterior segments' intrusion will be done using fixed appliances

    Device: miniscrew- supported maxillary posterior segments' intrusion using clear aligners

Interventions

  • Deviceminiscrew- supported maxillary posterior segments' intrusion using clear aligners

    maxillary posterior segments will be intruded with the aid of miniscrews and clear aligners

06

What researchers measure

Primary outcomes

  1. Anterior open bite closure

    the anterior open bite will be measured between the incisors using a digital caliper

    Time frame: 6 months

Secondary outcomes

  1. amount of maxillary posterior teeth intrusion

    the distance between the molar tri-furcation/premolar center to the Frankfurt Horizontal plane

    Time frame: 6 months

  2. Amount of mandibular posterior teeth extrusion

    the distance between molar bi-furcation or premolar center to the mandibular plane

    Time frame: 6 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2025, 12 months after the start.

Of 24 interventional studies with no phase under Open Bite, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2025
First posted
Aug 12, 2025
StartActual
Dec 30, 2024
Primary completionEst.
Dec 30, 2025
CompletionEst.
Feb 1, 2026
Last update
Aug 12, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07117006
Lead sponsor
Cairo University
Responsible party
Shady Mohamed Ali Elkelany (Resident at International Orthodontic Program (IOP), Cairo University) — Principal investigator
First posted
Aug 12, 2025
Start date
Dec 30, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Aug 12, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion