Not Yet RecruitingPhase 1

Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants

20 participantsStarted 2024-11-01

Plain-language 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.

Who can participate

Age range1 Day – 1 Month

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Non-syndromic Infants with complete BCLP infants * 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: * Patients above 1 month of age. * 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.

What they're measuring

Nasolabial esthetics

Timeframe: 4-6 months

Trial details

NCT IDNCT06589453

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-30

Contact for this trial

Donia Ayman Ahmed Ezzeldin, PhD

00201001200089 donia.ayman@dentistry.cu.edu.eg

View on ClinicalTrials.gov More Cleft Lip and Cleft Palate trials