Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants
NCT ID: NCT06589453
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2024-11-01
2026-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Nasal stent with Digital Nasoalveolar molding
Nasal stent with digital nasoalveolar molding 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
Nasal elevator with Digital Nasoalveolar molding
Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants.
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.
Interventions
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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 with digital nasoalveolar molding 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
Eligibility Criteria
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Inclusion Criteria
* Infants less than 1 month of age.
* Males and females.
* Infants with displaced premaxilla
* Patients whose parents provided written consent for the study.
Exclusion Criteria
* Syndromic and systemically ill infants.
* Patients with unilateral cleft lip and palate.
* Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).
* Medically compromised patients
* Patien parents/guardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.
1 Day
1 Month
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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: Donia Ayman Ahmed Ezzeldin ElSayed
Assistant lecturer at Orthodontic Department, Cairo University
Central Contacts
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Other Identifiers
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D-NAM 2024
Identifier Type: -
Identifier Source: org_study_id
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