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

NCT06589453 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-17

No results posted yet for this study

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

Interventions

DEVICE

Nasal 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.

DEVICE

Nasal 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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-03-30
Completion
2026-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06589453 on ClinicalTrials.gov