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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants
Device
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
Device
Nasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Nasal stent with Digital Nasoalveolar moldingActive comparator 1 intervention

Group B: Nasal elevator with Digital Nasoalveolar moldingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

Maxillary arch changes

Maxillary arch changes will be assessed in millimeters using maxillary digital models.

Time frame

4-6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: