Efficiency of a New Versatile Three-Way Maxillary Expander Versus Modified Fan Expander for Maxillary Arch Expansion in Cleft Lip and Palate Patients: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Maxillary arch development in Anteroposterior dimension
Overview
Brief Summary
This randomized controlled trial is designed to compare between Fan expander with palatal springs appliance vs three-way expander regarding the their effectiveness in maxillary expansion in patients with bilateral cleft
Detailed Description
The study provides three-dimensional expansion for cleft lip and palate patients. Patients with repaired cleft lip and/or palate have maxillary deficiency and hypoplasia in the three planes of space. Most cases have a normal buccolingual occlusal relation in the molar region between upper and lower jaws, while they manifest arch constriction at the anterior inter-canine width area as well as premaxillary collapse and anterior crossbite. Conventional expansion appliances address only the transverse discrepancy requiring a further step to re-align the premaxilla. So, the aim of the study is to compare the efficiency and the effects of the new design of the three-way palatal expander and the modified fan expander in maxillary arch development in cleft lip and palate patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 8 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with age ranging from 8 to 15 years old.
- •Patients with bilateral cleft lip and palate.
- •Patients with repaired cleft lip and / or palate.
- •Patients with fully erupted upper permanent 1st molars.
- •Patients in the late mixed or early permanent dentition with tapered maxillary arch, requiring palatal expansion as part of their treatment.
- •Patient's stage of cervical vertebral maturation before or at the growth spurt (CS1-CS4).
Exclusion Criteria
- •Patients with syndromic cleft lip and palate.
- •Patients with very bad oral hygiene and active periodontal disease.
- •Vulnerable groups
Outcomes
Primary Outcomes
Maxillary arch development in Anteroposterior dimension
Time Frame: [Time Frame: 6 - 12 months]
Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms
Secondary Outcomes
- Inter-canine width expansion in the transverse plane([Time Frame: 6- 12 months])
- Dental changes with expansion([Time Frame: 6- 12 months])