Maxilla; Hypoplasia, Posterior Crossbite
Conditions
Keywords
expander, maxillary transverse deficiency, posterior crossbite, mixed dentition
Brief 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.
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
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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
statistician
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain perception | first week after appliance insertion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| skeletal expansion | 6 months post 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 |
| dental tipping | 6 months post-expansion | Angular measurement of upper first molars angulation measured in degrees between pre- and post-coronal cuts of the CBCT |
| digital models parameters | six months post-expansion | Intermolar width, intercanine width |
Countries
Egypt
Outcome results
None listed