Actively Recruiting

Phase Not Applicable
Age: 12Years - 17Years
All Genders
Healthy Volunteers
ID07411092

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

Led by Ain Shams University · Updated on 2026-02-13

22

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the skeletal and dental effects of two types of Hyrax expanders used for maxillary arch expansion in adolescents with transverse maxillary deficiency. The study compares conventional Hyrax expanders and three-dimensionally printed Hyrax expanders, focusing on their precision, customization, and treatment outcomes. This research addresses a gap in clinical evidence during a critical developmental stage when maxillary expansion becomes more difficult due to suture maturation and resistance. Participants will be randomly assigned to receive either a 3D-printed Hyrax expander or a conventionally fabricated Hyrax expander designed for rapid maxillary expansion. Both devices aim to widen the maxillary arch but differ in manufacturing techniques—one uses additive 3D printing for a customized fit, while the other employs traditional laboratory fabrication methods. The intervention lasts for a treatment period of three weeks, with follow-up assessments up to six months post-expansion. During the study, participants will undergo cone-beam computed tomography (CBCT) scans and digital model evaluations to measure mid-palatal suture opening, dental expansion, tooth tipping, alveolar bone thickness, pain levels, and oral health-related quality of life. Stability of the skeletal expansion will be assessed six months after treatment. Participants will attend follow-up visits for monitoring and data collection, contributing to evidence-based orthodontic treatment planning.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged between 12 to 17 years
  • Skeletal age ranges from CVMS 3 to CVMS 5
  • Skeletal maxillary transverse deficiency with or without crossbite
  • Cooperative and able to attend follow-up visits
Not Eligible

You will not qualify if you...

  • 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, intellectual disabilities, or severe mental health disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation

Duration - 3 weeks

Participants receive either a three-dimensionally printed or conventionally fabricated Hyrax expander for rapid maxillary expansion.

1 visit for device placement and multiple visits for expansion adjustment

Follow-up

Duration - 6 months

Participants are monitored for stability of transverse skeletal width and oral health after expansion.

Periodic follow-up visits during the 6 months post-expansion

Trial Site Locations

Total: 1 location

1

Faculty of dentistry, Ain Shams univeristy

Cairo, Cairo Governorate, Egypt, 11566

Actively Recruiting

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Research Team

S

Sara S Mandour, Msc, Assistant lecturer

M

Marwah S Abdel-Latif, Msc, PHD, Lecturer

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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