Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Three dimensionally printed hyrax expander, Conventionally Fabricated Hyrax Expander.
- Who it may be relevant to
- Registry conditions: Transverse Maxillary Deficiency, Maxillary Expansion. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial
Overview
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.
Detailed description
Maxillary transverse deficiency is a common orthodontic problem that often requires skeletal expansion using appliances such as the Hyrax expander. While conventional Hyrax expanders have been widely used, advancements in digital dentistry have introduced 3D-printed alternatives that offer potential benefits in precision, customization, and patient comfort. However, there is currently no clinical evidence comparing the skeletal and dental effects of these two designs.
This study addresses this gap by evaluating and comparing the outcomes of conventional and 3D-printed Hyrax expanders in adolescent patients, a critical developmental stage where maxillary expansion becomes more challenging due to progressive maturation and increased resistance of the mid-palatal suture. The study uses cone-beam computed tomography (CBCT) and digital models to assess skeletal and dental changes, providing clinically relevant data to guide orthodontic treatment planning and appliance selection.
Interventions
- Device Three dimensionally printed hyrax expander
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. - Device Conventionally Fabricated Hyrax Expander
Group B: A conventionally fabricated Hyrax expander used for rapid maxillary expansion . The device is made using traditional laboratory techniques.
Primary outcome measures
- Amount of mid-palatal suture opening. [Time frame: Three weeks]
Secondary outcome measures (6)
- Amount of dental expansion [Time frame: Three weeks]
- The amount of tipping of maxillary molars and premolars. [Time frame: Three weeks]
- Change of buccal alveolar bone thickness. [Time frame: Three weeks]
- Pain assessment [Time frame: Three weeks]
- Oral health-related quality of life. [Time frame: Three weeks]
- Stability of transverse skeletal width at 6 months post-expansion [Time frame: Six months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of dentistry, Ain Shams univeristy — Cairo
Identifiers
NCT: NCT07411092 · FDASU-Rec IR/D072507