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

Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06589453

Acronym

D-NAM

Enrollment

Registered

2024-09-19

Start date

2024-11-01

Completion date

2026-10-01

Last updated

2024-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Cleft Palate

Keywords

Cleft lip and palate

Brief 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.

Detailed description

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.

Interventions

DEVICENasal 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.

DEVICENasal 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 1 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Nasolabial esthetics	4-6 months	Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.

Secondary

Measure	Time frame	Description
Maxillary arch changes	4-6 months	Maxillary arch changes will be assessed in millimeters using maxillary digital models.

Contacts

Primary ContactDonia Ayman Ahmed Ezzeldin, PhD

donia.ayman@dentistry.cu.edu.eg00201001200089

Backup ContactMohamed Abd-El-Ghafour Omar

m.abdelghafour@dentistry.cu.edu.eg00201007433288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026