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Recruiting NCT07301918

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

No phase Interventional Posterior Crossbite Maxilla; Hypoplasia

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: The Leaf expander, Hyrax expander.
Who it may be relevant to
Registry conditions: Posterior Crossbite, Maxilla; Hypoplasia. Basic parameters: 6 years — 12 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 →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Participants receive a banded maxillary expansion appliance cemented to maxillary first permanent molars, assigned to:

Leaf expander arm: Nickel-titanium leaf-spring expander, 9 mm screw, delivering force of \~900 g.

Hyrax expander arm: Conventional tooth-borne jackscrew expander, 9 mm screw. Standard activation: two turns per week.

Retention: Both appliances kept passively in situ for 6 months of retention following achievement of planned expansion.

Interventions

  • Device The Leaf expander
    The Leaf expander incorporates Nickel Titanium springs that will not require the patients' home activation
  • Device Hyrax expander
    Hyrax expander incorporates a screw that requires the patients' home activation

Primary outcome measures

  • Pain perception [Time frame: first week after appliance insertion]
Secondary outcome measures (3)
  • skeletal expansion [Time frame: 6 months post expansion]
  • dental tipping [Time frame: 6 months post-expansion]
  • digital models parameters [Time frame: six months post-expansion]

Eligibility criteria

Inclusion criteria

  • 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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Egypt · 1 center
  • Cairo University — Cairo

Identifiers

NCT: NCT07301918 · 24619942

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗