Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorCairo University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Male and female patients
Mixed dentition stage
Unilateral or bilateral posterior crossbite.
Patients in prepubertal stage with cervical vertebral maturation stage 1-3.
Disqualifiers
Previous orthodontic treatment.
Missing teeth.
Inadequate oral hygiene.
Patients with bad oral habits.
Trial design
Design model
Parallel
Treatments tested in this trial
The Leaf expander
DeviceThe Leaf expander incorporates Nickel Titanium springs that will not require the patients' home activation
Hyrax expander
DeviceHyrax expander incorporates a screw that requires the patients' home activation
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Banded Leaf expander supported on the maxillary first permanent molarsExperimental treatment 1 intervention
Group B: Banded Hyrax expander supported on the maxillary first permanent molarsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain perception
Pain perception during the first week after insertion using Wong-Becker faces scale with minimum value of zero and maximum value of ten, ten score represents the worst pain percieved.
Time frame
first week after appliance insertionSecondary outcomes
1
skeletal expansion
skeletal expansion using Cone Beam Computed Tomography skeletal expansion: linear distances of the midpalatal suture opening measured in mm between the pre- and post-axial cuts of the CBCT
Time frame
6 months post expansion2
dental tipping
Angular measurement of upper first molars angulation measured in degrees between pre- and post-coronal cuts of the CBCT
Time frame
6 months post-expansion3
digital models parameters
Intermolar width, intercanine width
Time frame
six months post-expansionSponsors and contacts
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Source ClinicalTrials.gov