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Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.

NCT06211205 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-18

No results posted yet for this study

Summary

Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.

The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.

Conditions

  • Cleft Lip and Palate

Interventions

DEVICE

Customized 3D printed nostril retainer combined with lip taping

the infants will receive a customised nostril retainer appliance to enhance the nasal esthetics combined with lip tape to approximate the labial and alveolar segments

PROCEDURE

Lip taping

the infants will receive lip tape to approximate the labial and alveolar segments

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-30
Primary Completion
2024-12-30
Completion
2025-06-30

Countries

  • Egypt

Study Locations

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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 NCT06211205 on ClinicalTrials.gov