Patient with unilateral cleft lip, with or without cleft palate, presenting with cleft-related nasal deformity and undergoing primary cheiloplasty with simultaneous primary rhinoplasty at an age of more than or equal 3 months old. Custom-made nostril retainer, 3D printing, Unilateral cleft lip with cleft lip nose deformity
Conditions
Interventions
For intervention group, patients view received 3D printing custommade nostril retainer which create one by one from patients basal view photography by our own invented program. The 3D printing customm
Active Comparator Other,Active Comparator Other
Custom-made nostril retainer group,Commercial nostril retainer group
Sponsors
Health Systems Research Institute (HSRI)
Eligibility
Sex/Gender
All
Age
3 Months to 7 Years
Inclusion criteria
Inclusion criteria: 1.had unilateral cleft lip with or without cleft palate 2.presented with cleft lip associated nasal deformity 3.underwent primary cheiloplasty with simultaneous primary rhinoplasty 4.were aged equal or more than 3 months at the time of surgery
Exclusion criteria
Exclusion criteria: 1.had syndromic cleft conditions 2.had known allergy to acrylic or silicone materials 3.were unable to comply with nostril retainer use (qual or less than 4 day/week or 2 hour/day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean difference of nostril width, mean difference of nostril height, width to height ratio at 1, 3, 6 months mean and standard deviation | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost, safety outcome, compliance at 1, 3, 6 months Mean, frequency, percentages | — |
Countries
Thailand
Contacts
Public ContactNutcha Yodrabum
Faculty of Medicine Siriraj Hospital, Mahidol University
Outcome results
None listed