The Efficacy of Clear Aligner versus Conventional Palatal Expanders in Unilateral Cleft Lip and Cleft Palate Patients
Phase 2
Recruiting
- Registration Number
- TCTR20240529002
- Lead Sponsor
- Smartee Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
Patients with neurological disorders or intellectual, cognitive deficits and poor compliance or communication disorders will be excluded from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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