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

Al-Azhar University

Status: Not yet enrolling

Conditions: Posterior Crossbite; Transverse Maxillary Deficiency; Maxillary Expansion

Treatments: Device: Quad Helix(QH) Appliance; Device: Rapid Maxillary Expanders

Study type: Interventional

Funder types: Other

Identifiers

NCT07500194

MG-ORTHO-2026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 9 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Group A:Quad Helix Appliance

Experimental group

Description:

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.

Treatment:

Device: Quad Helix(QH) Appliance

Group B: Rapid maxillary expanders

Active Comparator group

Description:

Participants in this group will receive treatment using fixed Rapid Maxillary Expanders (RME) bonded on the upper first permanent molars and pre-molars

Treatment:

Device: Rapid Maxillary Expanders