Q87.0 Q35.5
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Group 1: Patients with Piere Robin Sequenz and cleft palate Group 2: Patients with isolated cleft palates For both groups: 1. Ager: 5 years + 1 day to 6 years + 364 days (5 – 6 years) 2. Written approval by their legal guardians 3. cleft palate 4. Following surgery within the first 18 months of life. In addition for group 1: 5. Supply of intraoral appliance (baton plate) to 1 year
Exclusion criteria
Exclusion criteria: 1. Comorbidities 2. Additional syndrome or sequences 3. Supply of intraoral appliance (baton plate) longer than 1 year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Speech function after surgery on cleft palates at the age of 5 – 6 years according to GOSSPASS list respectively universally reporting parameters for LKGS malformation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparing neurologicals development (cognitive and motor development): Spastic, dyscinetic or atactic movement disorders defined in accordance with the SCPE-criteria, questionnaire about milestones in development on the study day (visit 1) 2. Growth of mandible and midface fixation (Assessment of the occlusion grade I-III according to Angle) 3. Number of remaining gaps in the palate | — |
Countries
Germany
Contacts
Klinik und Poliklinik für Mund, Kiefer- und GesichtschirurgieUniversitätsklinikum Tübingen