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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Transverse Maxillary Deficiency; Posterior Crossbite; Maxillary Expansion
• Intervention / Treatment: Device: Quad Helix(QH) Appliance; Device: Rapid Maxillary Expanders

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science; Phone Number: +201155874709 +201026896894; Email: moustafagalal.1.209@azhar.edu.eg

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 00000
      • Faculty of Dental medicine (boys) ,Cairo,Al-Azhar University
      • Contact: Moustafa G Saad, BDS; Phone Number: +201155874709 +201026896894; Email: moustafagalal.1.209@azhar.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A:Quad Helix Appliance; 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.	Device: Quad Helix(QH) Appliance; It is a fixed orthodontic appliance fabricated using stainless-steel wire and soldered to bands on upper first permanent molars.
Active Comparator: Group B: Rapid maxillary expanders; Participants in this group will receive treatment using fixed Rapid Maxillary Expanders (RME) bonded on the upper first permanent molars and pre-molars	Device: Rapid 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment duration	At the time of complete cross-bite correction (average of 6 months)

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Al Dany Atwa Mohamed, Professor, Faculty of dental medicine(boys) Cairo ,Al Azhar University; Study Director: Mahmoud Mohamed Fathy Abo ELMahasen, Associated Professor, Faculty of dental medicine(boys) Cairo ,Al Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Egyptian children; Rapid Maxillary Expansion; Randomized clinical trials; Quad Helix; Posterior cross-bite; Mixed Dentition
• Other Study ID Numbers: MG-ORTHO-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared to maintain participant confidentiality and because the data is proprietary to the Orthodontic Department at Al-Azhar University.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No