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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naso-alveolar molding (NAM) | Active Comparator | Active plates and nasal stents (Grayson method) |
|
| Computer aided design NAM (CAD/NAM) | Active Comparator | Computer aided design active plates and nasal stents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naso-alveolar molding (NAM) | Device |
| ||
| Computer aided design NAM (CAD/NAM) |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar alignment | Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments | 5-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal and labial esthetics | Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap | 5-6 months |
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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)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine, Cairo University | Cairo | Egypt |
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Blinding was done for the plastic surgeon (care provider) during lip repair and for the outcome assessor
| Device |
|
| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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