Evaluation of the Effects of the Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite: A Randomized Clinical Trial.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pain perception
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Masking Description
statistician
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts 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-
- •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.
Arms & Interventions
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
Intervention: The Leaf expander (Device)
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
Intervention: Hyrax expander (Device)
Outcomes
Primary Outcomes
Pain perception
Time Frame: 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 Outcomes
- skeletal expansion(6 months post expansion)
- dental tipping(6 months post-expansion)
Investigators
Noura Mohamed Hamza Hassan Saleh
Principal investigator
Cairo University