A Phase 1 interventional study of Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants and Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants in Cleft Lip and Cleft Palate, sponsored by Cairo University. Status unknown. Open to participants aged 1 Day to 1 Month. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Cairo University · Phase 1, Interventional, and Treatment
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.
167 studies on the registry are indexed under Cleft Lip; 53 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 117 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Device: Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants
Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants.
Device: Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants
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.
Nasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants
Nasolabial esthetics
Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.
Time frame: 4-6 months
Maxillary arch changes
Maxillary arch changes will be assessed in millimeters using maxillary digital models.
Time frame: 4-6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2024; primary completion for Mar 2026, 16 months later.
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This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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