Anterior CrossbiteNCT06015386
Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
A study testing inclined plane and clear aligner in people with Anterior Crossbite, run by Mansoura University at 1 site in Egypt.
Trial summary
the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Anterior Crossbite
- What is being tested?
- inclined plane and clear aligner
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2023to 30 Jul 2024
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
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.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry
Al Mansurah, 35511
Asmaa Mohammed, BDS, 1142820091 ext. 002, asmaasalah@mans.edu.eg
About this study
the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite
Read the detailed description
the study *include 24 patient each group include 12 patient where randomly allocated and intra-oral scanning is done for them followed by software designing ,printing using PETG sheets of 0.75 in aligner group while in inclined plane the appliance is formed in conventional way.
- Conditions
- Anterior Crossbite
- Being tested
- inclined plane, clear aligner
- Keywords
- clear aligner , anterior crossbite , inclined plane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inclined planeOther
2 parallel groups one treated with clear aligner and other treated using inclined plane
clear alignerOther
2 parallel groups one treated with clear aligner and other treated using inclined plane
| Study group | Role | What they receive |
|---|---|---|
| inclined plane | Experimental | group treated with inclined plane Receives: Other: inclined plane |
| clear aligner | Experimental | group treated with clear aligner Receives: Other: clear aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
(OHRQoL (Oral Health-related Quality of Life)
CPQ8-10 scores at two different points in time.
Measured: 4 month
Secondary outcomes (2)
cephalometric analysis of data
compare cephalometric variables between two groups
Measured: 4 month
3D model measurements
compare 3D model measurements variable between 2 group
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start22 Jun 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
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 Anterior CrossbiteStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Salah, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015386
- Sponsor's protocol ID
- ACB
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salem AS, Albelasy NF, El-Bialy AA. Effectiveness of clear aligner versus removable inclined plane in treatment of anterior crossbite in mixed dentition: A randomized clinical trial. J World Fed Orthod. 2025 Jun;14(3):125-130. doi: 10.1016/j.ejwf.2024.11.001. Epub 2024 Dec 19.
PubMed 39706691
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clear Aligner Versus Removable Inclined Plane in Treatment of Anterior Crossbite
- ClinicalTrials.gov ID
- NCT06015386
- Acronym / sponsor ID
- ACB
- Conditions
- Anterior Crossbite
- Keywords
- clear aligner , anterior crossbite , inclined plane
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 29 Aug 2023 (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.
the study is carried in faculty of dentistry Mansoura university to compare the efficiency and health quality life improvement between clear aligner and inclined plane in treatment of anterior crossbite
Detailed description
the study *include 24 patient each group include 12 patient where randomly allocated and intra-oral scanning is done for them followed by software designing ,printing using PETG sheets of 0.75 in aligner group while in inclined plane the appliance is formed in conventional way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inclined plane | Experimental | Other: inclined planegroup treated with inclined plane |
| clear aligner | Experimental | Other: clear alignergroup treated with clear aligner |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
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 |
|---|---|---|
| inclined plane2 parallel groups one treated with clear aligner and other treated using inclined plane | Other | inclined plane |
| clear aligner2 parallel groups one treated with clear aligner and other treated using inclined plane | Other | clear aligner |
Primary outcome
(OHRQoL (Oral Health-related Quality of Life)
Time frame: 4 month
CPQ8-10 scores at two different points in time.
2 secondary outcomes
cephalometric analysis of data
Time frame: 4 month
3D model measurements
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 39706691Salem AS, Albelasy NF, El-Bialy AA. Effectiveness of clear aligner versus removable inclined plane in treatment of anterior crossbite in mixed dentition: A randomized clinical trial. J World Fed Orthod. 2025 Jun;14(3):125-130. doi: 10.1016/j.ejwf.2024.11.001. Epub 2024 Dec 19.
- Individual participant dataSharing planned: No
Related trials for Anterior Crossbite
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Comparison Between Protraction Facemask and Upper Braces for Underbite Correction in Growing Children
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inclined plane and clear aligner in people with Anterior Crossbite, 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 0 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 29 Aug 2023. 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 Mohammed, BDS (1142820091 ext. 002, asmaasalah@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(OHRQoL (Oral Health-related Quality of Life) (time frame: 4 month). 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 NCT06015386, 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 29 Aug 2023.