Health TrialsbyHealthPanel

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

ConditionsTransverse Maxillary DeficiencyMaxillary Expansion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Previous orthodontic treatment.

Craniofacial syndromes, or cleft lip and/or palate.

Patients with vertical growth pattern.

Very bad oral hygiene and active periodontal disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

22 Participants
are divided into 2 treatment groups
Group A: Group A: 3D-Printed Hyrax ExpanderExperimental treatment 1 intervention
Group B: Group B: Conventionally Fabricated Hyrax ExpanderActive comparator 1 intervention

Trial outcomes

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

Time frame
Three weeks

Secondary outcomes

1

Amount of dental expansion

Dental expansion will be measured as changes in inter-canine width and intermolar width (in millimeters) on digital dental models.

Time frame
Three weeks
2

The amount of tipping of maxillary molars and premolars.

Buccolingual tipping of maxillary molars and premolars will be quantified as angular changes measured on CBCT by comparing pre-expansion and post-expansion images.

Time frame
Three weeks
3

Change of buccal alveolar bone thickness.

Changes in buccal alveolar bone thickness in millimeters will be measured on pre-expansion and post-expansion CBCT scans.

Time frame
Three weeks
4

Pain assessment

Evaluating the pain experienced during the active expansion phase using the Visual Analogue Scale (VAS; 0-100 mm), where 0 mm represents no pain and 100 mm represents the worst imaginable pain; the higher the value in the VAS scale, the more severe the pain.

Time frame
Three weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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