Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589453
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Evaluation of Nasal Elevator Versus Graysons Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Nasal Elevator Versus Graysons Nasal Stent in Conjunction with Digital Nasoalveolar Molding D-NAM Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate a Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
D-NAM
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None