Bilateral Cleft Lip and Palate, Maxillary Expansion
Conditions
Keywords
Bilateral cleft lip and palate, Expansion, Premaxilla, Three-dimensional expansion, Fan expander, Three- way expander
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.
Interventions
DEVICE3D Maxillary Expansion with 3 expansion screws
In patients requiring maxillary expansion, after randomization and allocation for each to receive which expander, appliance will be cemented. In the 3-way group (A), 3 screw activations will be delivered by the care giver to expand the maxillary arch in 3D manner correcting the collapsed arch anteriorly.
DEVICE3D Maxillary Expansion using modified Fan expander with springs
For the fan expander with palatal springs (B) , spring activation will be done by the operator after cemenation intraorally, then the care giver too will just activate one fan screw. Also 3D expansion evaluation was done.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maxillary arch development in Anteroposterior dimension | [Time Frame: 6 - 12 months] | Anterior expansion of the premaxilla in the sagittal plane measured through lateral Cephalograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-canine width expansion in the transverse plane | [Time Frame: 6- 12 months] | Inter-canine width expansion in the transverse plane measured on Digital dental models. |
| Dental changes with expansion | [Time Frame: 6- 12 months] | Amount of dental tipping occurring with expansion and amount of expansion and distal movement of maxillary molars |
Countries
Egypt
Outcome results
None listed