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Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.
The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.
Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while changes in the maxillary arch will be assessed by digital maxillary models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal stent with Digital Nasoalveolar molding | Active Comparator |
| |
| Nasal elevator with Digital Nasoalveolar molding | Experimental | Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants | Device | This is a unique nasal elevator aiming to improve nasolabial esthetics in conjunction with digital nasoalveolar molding appliance when used in bilateral cleft lip and palate infants. |
| Measure | Description | Time Frame |
|---|---|---|
| Nasolabial esthetics | Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy. | 4-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maxillary arch changes | Maxillary arch changes will be assessed in millimeters using maxillary digital models. | 4-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donia Ayman Ahmed Ezzeldin, PhD | Contact | 00201001200089 | donia.ayman@dentistry.cu.edu.eg | |
| Mohamed Abd-El-Ghafour Omar | Contact | 00201007433288 | m.abdelghafour@dentistry.cu.edu.eg |
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| Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants | Device | Nasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants |
|
| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| D002972 | Cleft Palate |
| 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 |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
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