Cleft Lip and Palate
Conditions
Brief summary
Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.
Interventions
DEVICENaso-alveolar molding (NAM)
DEVICEComputer aided design NAM (CAD/NAM)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor
Eligibility
Sex/Gender
ALL
Age
7 Days to 60 Days
Healthy volunteers
No
Inclusion criteria
• Bilateral cleft lip and palate
Exclusion criteria
Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alveolar alignment | 5-6 months | Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal and labial esthetics | 5-6 months | Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap |
Countries
Egypt
Outcome results
None listed