Posterior CrossbiteExpansionNCT07500194
Quad Helix vs RME for Posterior Cross-bite in Egyptian Children
A study testing Quad Helix(QH) Appliance and Rapid Maxillary Expanders in people with Posterior Crossbite and Maxillary Expansion, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This randomized clinical trial aims to evaluate and compare the effectiveness of the Quad Helix (QH) appliance versus Rapid Maxillary Expanders (RME) in treating posterior cross-bite in Egyptian children during the mixed dentition stage. Read more about this study
- Who is it for?
- Ages 9 to 12 years
- Conditions the study is for
- Posterior Crossbite, Maxillary Expansion, Transverse Maxillary Deficiency
- What is being tested?
- Quad Helix(QH) Appliance and Rapid Maxillary Expanders
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2026to 31 Mar 2028
- 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 9 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 9-12 years in the mixed dentition stage
- Presence of posterior cross-bite due to transverse maxillary deficiency
- No previous history of orthodontic treatment
- Good oral hygiene and cooperative behavior
- No significant antero-posterior or vertical skeletal discrepancies
Who cannot join
- Patient with craniofacial anomalies
- Presence of systemic diseases or syndromes affecting bone metabolism
- Extensive dental caries or untreated periodontal disease
- History of trauma or surgery affecting the maxilla or mandible
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science contact
Egypt1 site
Faculty of Dental medicine (boys) ,Cairo,Al-Azhar University
Cairo, Cairo Governorate, 00000
Moustafa G Saad, BDS, +201026896894 ext. +201155874709, moustafagalal.1.209@azhar.edu.eg
About this study
Official title: Quad Helix Versus Rapid Maxillary Expanders in the Treatment of Posterior Cross-bite During Mixed Dentition in a Sample of Egyptian Children: A Randomized Clinical Study.
This randomized clinical trial aims to evaluate and compare the effectiveness of the Quad Helix (QH) appliance versus Rapid Maxillary Expanders (RME) in treating posterior cross-bite in Egyptian children during the mixed dentition stage. The study will also assess patient comfort and pain levels associated with each appliance.
Read the detailed description
The study involves 20 orthodontic patients aged 9-12 years with posterior cross-bite. Group A will receive the Quad Helix appliance, while Group B will receive Rapid Maxillary Expanders. Evaluation will be based on orthodontic study models, clinical photographs, and various radiographs including CBCT. Treatment will continue until complete correction is achieved, followed by a 3-month passive retention period.
- Being tested
- Quad Helix(QH) Appliance, Rapid Maxillary Expanders
- Keywords
- Quad Helix, Rapid Maxillary Expansion, Posterior cross-bite, Mixed Dentition, Egyptian children, Randomized clinical trials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quad Helix(QH) ApplianceDevice
It is a fixed orthodontic appliance fabricated using stainless-steel wire and soldered to bands on upper first permanent molars.
Rapid Maxillary ExpandersDevice
It is a fixed expansion device bonded on the upper first permanent molars and pre-molars. Activation is done at a rate of 0.25 mm twice daily (two turns per day)
| Study group | Role | What they receive |
|---|---|---|
| Group A:Quad Helix Appliance | Experimental | Participants in this group will receive treatment using a fixed Quad Helix (QH) appliance to correct posterior cross-bite. The appliance is fabricated using stainless steel wire and soldered to bands on the upper first permanent molars. Receives: Device: Quad Helix(QH) Appliance |
| Group B: Rapid maxillary expanders | Active comparator | Participants in this group will receive treatment using fixed Rapid Maxillary Expanders (RME) bonded on the upper first permanent molars and pre-molars Receives: Device: Rapid Maxillary Expanders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maxillary Arch Width Changes
Measured on dental castes at the level of inter molar / inter canine width and Cone-beam computed tomography (CBCT) for upper arch
Measured: Baseline and 6 months
Secondary outcomes (1)
Treatment duration
Measured: At the time of complete cross-bite correction (average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior CrossbiteStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Model description
- A randomized controlled clinical trial with two parallel groups. Patients are randomly assigned to either receive the Quad Helix appliance (Group A) or the Rapid Maxillary Expander (Group B)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Galal Borham Moustafa Saad, Al-Azhar University
- Investigators
- Al Dany Atwa Mohamed, Professor, Study chair, Faculty of dental medicine(boys) Cairo ,Al Azhar UniversityMahmoud Mohamed Fathy Abo ELMahasen, Associated Professor, Study director, Faculty of dental medicine(boys) Cairo ,Al Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500194
- Sponsor's protocol ID
- MG-ORTHO-2026
- Acronym
- Expansion
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to maintain participant confidentiality and because the data is proprietary to the Orthodontic Department at Al-Azhar University.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quad Helix Versus Rapid Maxillary Expanders in the Treatment of Posterior Cross-bite During Mixed Dentition in a Sample of Egyptian Children: A Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT07500194
- Acronym / sponsor ID
- Expansion / MG-ORTHO-2026
- Keywords
- Quad Helix, Rapid Maxillary Expansion, Posterior cross-bite, Mixed Dentition, Egyptian children, Randomized clinical trials
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 30 Mar 2026 (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.
This randomized clinical trial aims to evaluate and compare the effectiveness of the Quad Helix (QH) appliance versus Rapid Maxillary Expanders (RME) in treating posterior cross-bite in Egyptian children during the mixed dentition stage. The study will also assess patient comfort and pain levels associated with each appliance.
Detailed description
The study involves 20 orthodontic patients aged 9-12 years with posterior cross-bite. Group A will receive the Quad Helix appliance, while Group B will receive Rapid Maxillary Expanders. Evaluation will be based on orthodontic study models, clinical photographs, and various radiographs including CBCT. Treatment will continue until complete correction is achieved, followed by a 3-month passive retention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial with two parallel groups. Patients are randomly assigned to either receive the Quad Helix appliance (Group A) or the Rapid Maxillary Expander (Group B)
| Arm | Type | Receives |
|---|---|---|
| Group A:Quad Helix Appliance | Experimental | Device: Quad Helix(QH) ApplianceParticipants in this group will receive treatment using a fixed Quad Helix (QH) appliance to correct posterior cross-bite. The appliance is fabricated using stainless steel wire and soldered to bands on the upper first permanent molars. |
| Group B: Rapid maxillary expanders | Active comparator | Device: Rapid Maxillary ExpandersParticipants in this group will receive treatment using fixed Rapid Maxillary Expanders (RME) bonded on the upper first permanent molars and pre-molars |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 9-12 years in the mixed dentition stage
- Presence of posterior cross-bite due to transverse maxillary deficiency
- No previous history of orthodontic treatment
- Good oral hygiene and cooperative behavior
- No significant antero-posterior or vertical skeletal discrepancies
Key exclusion criteria (4 listed)
- Patient with craniofacial anomalies
- Presence of systemic diseases or syndromes affecting bone metabolism
- Extensive dental caries or untreated periodontal disease
- History of trauma or surgery affecting the maxilla or mandible
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 |
|---|---|---|
| Quad Helix(QH) ApplianceIt is a fixed orthodontic appliance fabricated using stainless-steel wire and soldered to bands on upper first permanent molars. | Device | Group A:Quad Helix Appliance |
| Rapid Maxillary ExpandersIt is a fixed expansion device bonded on the upper first permanent molars and pre-molars. Activation is done at a rate of 0.25 mm twice daily (two turns per day) | Device | Group B: Rapid maxillary expanders |
Primary outcome
Maxillary Arch Width Changes
Time frame: Baseline and 6 months
Measured on dental castes at the level of inter molar / inter canine width and Cone-beam computed tomography (CBCT) for upper arch
1 secondary outcome
Treatment duration
Time frame: At the time of complete cross-bite correction (average of 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 30 Mar 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to maintain participant confidentiality and because the data is proprietary to the Orthodontic Department at Al-Azhar University.
Related trials for Posterior Crossbite
Active, not recruiting
Evaluation of Myobrace for Crossbite Correction in Mixed Dentition
Cross Bite
Not yet recruiting
Evaluation of Occlusal Force Following Rapid Maxillary Expansion Assisted by Piezocision in Different Age Groups
Maxillary Transverse Deficiency, Rapid Maxillary Expansion
Recruiting
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents
Maxillary Transverse Deficiency (Posterior Crossbite) in Early Adolescent Patients
Recruiting
Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
Posterior Crossbite, Maxilla; Hypoplasia
Not yet recruitingObservational study
Correlation Between Posterior Crossbite and Risk of Obstructive Sleep Apnea
Crossbite Teeth
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.
Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science contact
Al Dany Atwa Mohamed, Professor study chair
Faculty of dental medicine(boys) Cairo ,Al Azhar University
Mahmoud Mohamed Fathy Abo ELMahasen, Associated Professor study director
Faculty of dental medicine(boys) Cairo ,Al Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quad Helix(QH) Appliance and Rapid Maxillary Expanders in people with Posterior Crossbite and Maxillary Expansion, run by Al-Azhar 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 5 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: opening soon, as of the sponsor's last update on 30 Mar 2026. 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?
Contact Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science (+201026896894 ext. +201155874709, moustafagalal.1.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary Arch Width Changes (time frame: Baseline and 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 30 Mar 2026.