The presence of a cleft in the palate, with or without a cleft in the lip, is considered the fourth most common congenital malformation and the most common craniofacial anomaly. The common manifestations of CLCP involve disruption of tissue planes above the lip, extending into the nares and/or the palate (hard and/or soft).Development of the lip and palate involves a complex series of events that require close coordination of programs for cell migration, growth, differentiation, and apoptosis. B
Conditions
Interventions
An orthodontic clear aligner is a transparent, removable dental appliance designed to straighten teeth and correct malocclusions. Made from a medical-grade thermoplastic material, clear aligners are c
s teeth, gradually applying pressure to move them into the desired position. They offer a discreet alternative to traditional metal braces and can be removed for eating, brushing, and flossing, provid
Experimental Device,Active Comparator Device
Clear aligners,Conventional palatal expander
Sponsors
Smartee Thailand
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Non-syndromic unilateral cleft lip and palate (UCLCP), who necessitate intervention prior to SABG 6-12 years of age Normal hearing function Early mixed dentition Good cooperation Ability to produce a repetition of perceptually acceptable sounds
Exclusion criteria
Exclusion criteria: Patients with neurological disorders or intellectual, cognitive deficits and poor compliance or communication disorders will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alteration of arch parameters from T0 to T3 between clear aligner and conventional palatal expanders T0: before appliance insertion; T1: immediately after appliance insertion; and T2: 4 weeks after appliance insertion; T3: prior to SABG Measurement in digital models | — |
Secondary
| Measure | Time frame |
|---|---|
| Differences in vowel space area among T0, T1, T2 and T3 in the same individuals and the correlation of these differences with palatal morphology T0: before appliance insertion; T1: immediately after appliance insertion; and T2: 4 weeks after appliance insertion; T3: prior to SABG PRAAT software version 6.0.40 | — |
Countries
Thailand
Outcome results
None listed