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NCT Number: NCT07411092

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

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.

Recruiting

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry, Ain Shams univeristy

Cairo, Cairo Governorate, 11566, Egypt

Location status: Recruiting

Location contact

Sara Sherif Saleh Sherif Assistant lecturer, A

CONTACT

[email protected]

+20 1061531431

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Amount of mid-palatal suture opening.

    Time frame: Three weeks

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

Secondary outcomes

  1. Amount of dental expansion

    Time frame: Three weeks

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

  2. The amount of tipping of maxillary molars and premolars.

    Time frame: Three weeks

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

  3. Change of buccal alveolar bone thickness.

    Time frame: Three weeks

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

  4. Pain assessment

    Time frame: Three weeks

    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.

  5. Oral health-related quality of life.

    Time frame: Three weeks

    Oral health-related quality of life was assessed using the Oral Health Impact Profile-14 (OHIP-14). Items are rated on a 5-point Likert scale (0 = never to 4 = very often). Results are presented as mean scores (0-4); higher values indicate worse oral health-related quality of life.

  6. Stability of transverse skeletal width at 6 months post-expansion

    Time frame: Six months

    The transverse skeletal dimension after appliance removal after six months post-expansion will be measured in the axial plane on the CBCT X-ray.

Study contacts

Contact information is provided by the study sponsor or research team.

Marwah S Abdel-Latif, Msc, PHD, Lecturer

CONTACT

[email protected]

+201002955774

Sara S Mandour, Msc, Assistant lecturer

CONTACT

[email protected]

+201061531431

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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