Cleft Lip and Palate
Conditions
Interventions
DPNAM group:3D-printed palatal plates and nasal hooks, elastic adhesive tape
CPNAM group:Conventional PNAM appliances and elastic tape
Sponsors
Hospital of Stomatology, Wuhan University
Eligibility
Sex/Gender
All
Age
No minimum to 0.1 Years
Inclusion criteria
Inclusion criteria: 1.The subject's family provides written informed consent prior to participation; 2.The subject is a full-term infant (gestational age at birth > 37 weeks) and within 30 days after birth at enrollment; 3.The subject is a non-low birth weight infant (low birth weight = 2500g); 4.The subject is diagnosed with non-syndromic cleft lip and palate; 5.The subject has unilateral complete cleft lip and palate; 6.The subject has completed laboratory tests including but not limited to: complete blood count, liver and kidney function tests, with no clinically significant abnormalities in the test results; 7.The subject has completed imaging examinations including but not limited to: chest X-ray, echocardiogram, with no clinically significant abnormalities in the examination results.
Exclusion criteria
Exclusion criteria: 1.The subject has other systemic diseases; 2.The subject experienced hypoxia at birth; 3.The subject has abnormal growth and development assessment results; 4.The subject's family members refuse to provide written informed consent prior to participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Three-dimensional morphology of the maxilla;Nasal-labial soft tissue morphology; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-related psychosocial health and family impact; | — |
Countries
China
Contacts
Public ContactHong He
Hospital of Stomatology, Wuhan University
Outcome results
None listed