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Quad Helix vs RME for Posterior Cross-bite in Egyptian Children

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07500194
Acronym
Expansion
Enrollment
20
Registered
2026-03-30
Start date
2026-03-30
Completion date
2028-03-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Expansion, Posterior Crossbite, Transverse Maxillary Deficiency

Keywords

Quad Helix, Rapid Maxillary Expansion, Posterior cross-bite, Mixed Dentition, Egyptian children, Randomized clinical trials

Brief 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. 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.

Interventions

DEVICEQuad Helix(QH) Appliance

It is a fixed orthodontic appliance fabricated using stainless-steel wire and soldered to bands on upper first permanent molars.

DEVICERapid Maxillary Expanders

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)

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

It is an open-label study where both the participants and investigators are aware of the assigned intervention due to the nature of the orthodontic appliances used

Intervention 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)

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

1. Children aged 9-12 years in the mixed dentition stage 2. Presence of posterior cross-bite due to transverse maxillary deficiency 3. No previous history of orthodontic treatment 4. Good oral hygiene and cooperative behavior 5. No significant antero-posterior or vertical skeletal discrepancies

Exclusion criteria

1. Patient with craniofacial anomalies 2. Presence of systemic diseases or syndromes affecting bone metabolism 3. Extensive dental caries or untreated periodontal disease 4. History of trauma or surgery affecting the maxilla or mandible

Design outcomes

Primary

MeasureTime frameDescription
Maxillary Arch Width ChangesBaseline and 6 monthsMeasured on dental castes at the level of inter molar / inter canine width and Cone-beam computed tomography (CBCT) for upper arch

Secondary

MeasureTime frame
Treatment durationAt the time of complete cross-bite correction (average of 6 months)

Countries

Egypt

Contacts

CONTACTMoustafa Galal Borham Moustafa Saad, Bachelor of dental Science
moustafagalal.1.209@azhar.edu.eg+201026896894
STUDY_CHAIRAl Dany Atwa Mohamed, Professor

Faculty of dental medicine(boys) Cairo ,Al Azhar University

STUDY_DIRECTORMahmoud Mohamed Fathy Abo ELMahasen, Associated Professor

Faculty of dental medicine(boys) Cairo ,Al Azhar University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026