Dental MalocclusionNCT04713280
Maxillary Versus Bi-Maxillary Posterior Segments Intrusion Adult Subjects With Skeletal Open Bite
A study testing Maxillary posterior dento-alveolar intrusion in people with Dental Malocclusion, run by Cairo University at 1 site in Egypt.
Trial summary
Compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion and maxillary posterior dento-alveolar intrusion as regards open bite closure. Read more about this study
- Who is it for?
- Ages 17 to 25 years
- Conditions the study is for
- Dental Malocclusion
- What is being tested?
- Maxillary posterior dento-alveolar intrusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Sep 2020to 1 Dec 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 17 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Skeletal open bite with a dental open bite ranging from 3-8 mm.
- Adequate incisal show at rest and on smiling
- Full set of posterior teeth from first premolar to second molar (with the exception of one tooth in one quadrant).
Who cannot join
- Dental open bites without skeletal components
- Previous orthodontic treatment
- Medically compromised patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Orthodontic Department, Faculty of Dentistry, Cairo University
Cairo, 11451
About this study
Official title: Maxillary Versus Bi-Maxillary Posterior Segments Intrusion in Treatment of Adult Subjects With Skeletal Open Bite - A Randomized Clinical Trial
Compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion and maxillary posterior dento-alveolar intrusion as regards open bite closure.
Read the detailed description
Now, maxillary posterior dento-alveolar intrusion has been validated as a conservative treatment modality for treatment of skeletal open bite in adult patients. However, it was proved that mandibular posterior teeth extrusion take place during the treatment which results in reduction in the amount of open. bite closure. Therefore, the aim of our study is to compare in a randomized clinical trial methodology between maxillary posterior dento-alveolar intrusion and combined maxillary and mandibular posterior dento-alveolar intrusion in terms of anterior open bite closure.
- Conditions
- Dental Malocclusion
- Being tested
- Maxillary posterior dento-alveolar intrusion
- Keywords
- molar intrusion, open bite, mini-screws
- Medical subject headings
- Malocclusion, Open Bite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary posterior dento-alveolar intrusionProcedure or surgery
Also called Bi-maxillary posterior dento-alveolar intrusion
Mini-screw supported maxillary or bi-maxillary posterior dento-alveolar intrusion
| Study group | Role | What they receive |
|---|---|---|
| Maxillary posterior dento-alveolar intrusion | Active comparator | Mini-screw supported maxillary posterior dento-alveolar intrusion Receives: Procedure: Maxillary posterior dento-alveolar intrusion |
| Bi-maxillary posterior dento-alveolar intrusion | Experimental | Mini-screw supported bi-maxillary posterior dento-alveolar intrusion Receives: Procedure: Maxillary posterior dento-alveolar intrusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior open bite closure
The amount of overbite gained as a result of posterior dento-alveolar intrusion
Measured: 6 months
Secondary outcomes (3)
Maxillary posterior teeth intrusion radiographically in millimeters.
The distance travelled by maxillary premolars and molars of the right and left sides to a reference plane
Measured: 6 months
Mandibular posterior teeth intrusion radiographically in millimeters.
The distance travelled by mandibular premolars and molars of the right and left sides to a reference plane
Measured: 6 months
Tip and torque of intruded teeth radiographically in degrees.
- Torque change is measured as the change in the angle between the long axis of the intruded teeth and the FH plane (for tip) mid-sagittal plane (for torque).
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 posted19 Jan 2021
- Study start17 Sep 2020
- Primary completion30 Sep 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental MalocclusionStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba El-Sayed Kamel Akl, Cairo University
- Investigators
- Heba Akl, MSc., Principal investigator, Assistant lecturer, PhD candidate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713280
- Sponsor's protocol ID
- 2098765
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akl HE, Abouelezz AM, El Sharaby FA, Abd-El-Ghafour M, El-Beialy AR. Is mandibular posterior dento-alveolar intrusion essential in treatment of skeletal open bite in adult patients? A single center randomized clinical trial. BMC Oral Health. 2025 Apr 7;25(1):500. doi: 10.1186/s12903-025-05778-w.
PubMed 40197278
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillary Versus Bi-Maxillary Posterior Segments Intrusion in Treatment of Adult Subjects With Skeletal Open Bite - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04713280
- Acronym / sponsor ID
- 2098765
- Conditions
- Dental Malocclusion
- Keywords
- molar intrusion, open bite, mini-screws
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 Jan 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.
Compare between bi-maxillary (maxillary and mandibular) posterior dento-alveolar intrusion and maxillary posterior dento-alveolar intrusion as regards open bite closure.
Detailed description
Now, maxillary posterior dento-alveolar intrusion has been validated as a conservative treatment modality for treatment of skeletal open bite in adult patients. However, it was proved that mandibular posterior teeth extrusion take place during the treatment which results in reduction in the amount of open. bite closure. Therefore, the aim of our study is to compare in a randomized clinical trial methodology between maxillary posterior dento-alveolar intrusion and combined maxillary and mandibular posterior dento-alveolar intrusion in terms of anterior open bite closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maxillary posterior dento-alveolar intrusion | Active comparator | Procedure: Maxillary posterior dento-alveolar intrusionMini-screw supported maxillary posterior dento-alveolar intrusion |
| Bi-maxillary posterior dento-alveolar intrusion | Experimental | Procedure: Maxillary posterior dento-alveolar intrusionMini-screw supported bi-maxillary posterior dento-alveolar intrusion |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Skeletal open bite with a dental open bite ranging from 3-8 mm.
- Adequate incisal show at rest and on smiling
- Full set of posterior teeth from first premolar to second molar (with the exception of one tooth in one quadrant).
Key exclusion criteria (3 listed)
- Dental open bites without skeletal components
- Previous orthodontic treatment
- Medically compromised patients
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 posterior dento-alveolar intrusionAlso: Bi-maxillary posterior dento-alveolar intrusionMini-screw supported maxillary or bi-maxillary posterior dento-alveolar intrusion | Procedure or surgery | Bi-maxillary posterior dento-alveolar intrusion, Maxillary posterior dento-alveolar intrusion |
Primary outcome
Anterior open bite closure
Time frame: 6 months
The amount of overbite gained as a result of posterior dento-alveolar intrusion
3 secondary outcomes
Maxillary posterior teeth intrusion radiographically in millimeters.
Time frame: 6 months
Mandibular posterior teeth intrusion radiographically in millimeters.
Time frame: 6 months
Tip and torque of intruded teeth radiographically in degrees.
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 7 Feb 2024.
- Derived from this study: PubMed 40197278Akl HE, Abouelezz AM, El Sharaby FA, Abd-El-Ghafour M, El-Beialy AR. Is mandibular posterior dento-alveolar intrusion essential in treatment of skeletal open bite in adult patients? A single center randomized clinical trial. BMC Oral Health. 2025 Apr 7;25(1):500. doi: 10.1186/s12903-025-05778-w.
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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.
Heba Akl, MSc. principal investigator
Assistant lecturer, PhD candidate
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 posterior dento-alveolar intrusion in people with Dental Malocclusion, 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 3 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 7 Feb 2024. 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?
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?
On the ClinicalTrials.gov record for NCT04713280, which also lists 1 linked publication.
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 7 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.