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

NCT ID: NCT07301918

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Posterior Crossbite Maxilla; Hypoplasia

Keywords

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expander maxillary transverse deficiency posterior crossbite mixed dentition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
statistician

Study Groups

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Banded Leaf expander supported on the maxillary first permanent molars

9mm leaf expander delievering 900 gm force will be supported on the upper first permanent molars with the appliance arm extending to the canines

Group Type EXPERIMENTAL

The Leaf expander

Intervention Type DEVICE

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

Banded Hyrax expander supported on the maxillary first permanent molars

9mm Hyrax expander will be supported on the upper first permanent molars with the appliance arm extending to the canines

Group Type ACTIVE_COMPARATOR

Hyrax expander

Intervention Type DEVICE

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

Interventions

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The Leaf expander

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

Intervention Type DEVICE

Hyrax expander

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Noura Mohamed Hamza Hassan Saleh

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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24619942

Identifier Type: -

Identifier Source: org_study_id