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NCT Number: NCT07500194

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

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.

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Key information

Conditions

Posterior Crossbite Maxillary Expansion Transverse Maxillary Deficiency

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental medicine (boys) ,Cairo,Al-Azhar University

Cairo, Cairo Governorate, 00000, Egypt

Location contact

Moustafa G Saad, BDS

CONTACT

[email protected]

+201026896894 ext. +201155874709

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Quad Helix(QH) Appliance

Device

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

Rapid Maxillary Expanders

Device

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. Treatment duration

    Time frame: At the time of complete cross-bite correction (average of 6 months)

Study contacts

Contact information is provided by the study sponsor or research team.

Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science

CONTACT

[email protected]

+201026896894 ext. +201155874709

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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.

Acronym: Expansion

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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