Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents

NCT07411092 | Recruiting DMC

• 1 other identifier: FDASU-Rec IR/D072507
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to compare the skeletal and dental effects of conventional Hyrax expanders and 3D-printed Hyrax expanders in adolescent patients with maxillary transverse deficiency. Using cone-beam computed tomography (CBCT) and digital models, the study evaluates the precision, customization, and treatment outcomes of both appliance types to inform evidence-based orthodontic treatment planning.

Conditions

Transverse Maxillary Deficiency; Maxillary Expansion

Keywords

Maxillary Expansion; Hyrax expander

Outcome Measures

Primary Outcomes (1)

• Amount of mid-palatal suture opening.

  The amount of suture separation measured in millimeters in the axial plane through CBCT X-ray

  Three weeks

Secondary Outcomes (6)

• Amount of dental expansion

  Three weeks

• The amount of tipping of maxillary molars and premolars.

  Three weeks

• Change of buccal alveolar bone thickness.

  Three weeks

• Pain assessment

  Three weeks

• Oral health-related quality of life.

  Three weeks

Study Arms (2)

Group A: 3D-Printed Hyrax Expander

EXPERIMENTAL

Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using a three-dimensionally printed Hyrax expander.

Device: Three dimensionally printed hyrax expander

Group B: Conventionally Fabricated Hyrax Expander

ACTIVE COMPARATOR

Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using using a conventionally fabricated Hyrax expander.

Device: Conventionally Fabricated Hyrax Expander

Interventions

Three dimensionally printed hyrax expander DEVICE

Group A : A 3D-printed Hyrax expander designed for rapid maxillary expansion in orthodontic treatment. The device is manufactured using additive manufacturing technology for a customized fit.

Group A: 3D-Printed Hyrax Expander

Conventionally Fabricated Hyrax Expander DEVICE

Group B: A conventionally fabricated Hyrax expander used for rapid maxillary expansion . The device is made using traditional laboratory techniques.

Group B: Conventionally Fabricated Hyrax Expander

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged between 12 to 17 years.
• Skeletal age ranges from CVMS 3 to CVMS 5.
• Skeletal maxillary transverse deficiency with/without crossbite.
• Cooperative and able to attend follow-up visits.

You may not qualify if:

• Previous orthodontic treatment.
• Craniofacial syndromes, or cleft lip and/or palate.
• Patients with vertical growth pattern.
• Very bad oral hygiene and active periodontal disease.
• Vulnerable groups such as individuals with cognitive impairments or intellectual disabilities and individuals with severe mental health disorders.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of dentistry, Ain Shams univeristy

Cairo, Cairo Governorate, 11566, Egypt

RECRUITING

Central Study Contacts

Sara S Mandour, Msc, Assistant lecturer

CONTACT

+201061531431; sarasaleh@dent.asu.edu.eg

Marwah S Abdel-Latif, Msc, PHD, Lecturer

CONTACT

+201002955774; marwahsalah@asfd.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 13, 2026
• Study Start: August 1, 2025
• Primary Completion: August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)