NCT07500194

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Mar 2026Mar 2028

First Submitted

Initial submission to the registry

March 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

March 20, 2026

Last Update Submit

March 24, 2026

Conditions

Posterior CrossbiteMaxillary ExpansionTransverse Maxillary Deficiency

Keywords

Quad HelixRapid Maxillary ExpansionPosterior cross-biteMixed DentitionEgyptian childrenRandomized clinical trials

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Treatment duration

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

Study Arms (2)

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.

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

Device: Rapid Maxillary Expanders

Interventions

Quad Helix(QH) ApplianceDEVICE

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

Group A:Quad Helix Appliance
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)

Group B: Rapid maxillary expanders

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Cairo Governorate, 00000, Egypt

Location

Study Officials

  • Al Dany Atwa Mohamed, Professor

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

    STUDY CHAIR

  • Mahmoud Mohamed Fathy Abo ELMahasen, Associated Professor

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

    STUDY DIRECTOR

Central Study Contacts

Moustafa Galal Borham Moustafa Saad, Bachelor of dental Science

CONTACT

+201026896894moustafagalal.1.209@azhar.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist at orthodontic Department, Faculty of dental medicine, Al Azhar University

Study Record Dates

First Submitted

March 20, 2026

First Posted

March 30, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

IPD will not be shared to maintain participant confidentiality and because the data is proprietary to the Orthodontic Department at Al-Azhar University.

Locations

EG(1)