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

ConditionCleft Lip and Cleft Palate

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age1-1

SponsorCairo University

About this trial

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.

Eligibility criteria

Qualifiers

Non-syndromic Infants with complete BCLP infants

Infants less than 1 month of age.

Males and females.

Infants with displaced premaxilla

Disqualifiers

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).

Trial design

Treatments tested in this trial

Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants
Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants

Treatment groups

20 Participants

are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Cairo University

Lead sponsor

Source ClinicalTrials.gov