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RecruitingNot ApplicableNCT07301918

Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.

Evaluation of the Effects of the Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite: A Randomized Clinical Trial.

Sponsor

Cairo University

Enrollment

30 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Posterior CrossbiteMaxilla; Hypoplasia

Summary

Design: Two-arm parallel randomized clinical trial in mixed dentition (6-12 years). Arms: (1) 9 mm, 900 g leaf expander; (2) 9 mm Hyrax expander. Follow-up: From appliance insertion → completion of intended expansion → 6-month retention. Primary outcome: Pain perception during the first 7 days post-insertion (daily patient-reported scale). Secondary outcomes: Skeletal and dental changes on CBCT.

Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria6

  • Male and female patients
  • Mixed dentition stage
  • Unilateral or bilateral posterior crossbite.
  • Patients in prepubertal stage with cervical vertebral maturation stage 1-3.
  • Fully erupted maxillary and mandibular permanent first molars.
  • Skeletal class I or II.

Exclusion Criteria6

  • Previous orthodontic treatment.
  • Missing teeth.
  • Inadequate oral hygiene.
  • Patients with bad oral habits.
  • Patients with medical conditions.
  • Patients with cleft lip and palate.

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Interventions

DEVICEThe Leaf expander

The Leaf expander incorporates Nickel Titanium springs that will not require the patients' home activation

DEVICEHyrax expander

Hyrax expander incorporates a screw that requires the patients' home activation

Locations(1)

Cairo University

Cairo, Egypt

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NCT07301918