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

NCT06589453 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: D-NAM 2024
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Lip and Cleft Palate

Keywords

Cleft lip and palate

Outcome Measures

Primary Outcomes (1)

• Nasolabial esthetics

  Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.

  4-6 months

Secondary Outcomes (1)

• Maxillary arch changes

  4-6 months

Study Arms (2)

Nasal stent with Digital Nasoalveolar molding

ACTIVE COMPARATOR

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

Nasal elevator with Digital Nasoalveolar molding

EXPERIMENTAL

Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants.

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

Interventions

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 elevator with Digital Nasoalveolar molding

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

Nasal stent with Digital Nasoalveolar molding

Eligibility Criteria

• Age: 1 Day - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Cleft Lip; Cleft Palate

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Central Study Contacts

Donia Ayman Ahmed Ezzeldin, PhD

CONTACT

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

Mohamed Abd-El-Ghafour Omar

CONTACT

00201007433288; m.abdelghafour@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer at Orthodontic Department, Cairo University

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-09