Skip to main content
OpenTrials
Completed

NCT Number: NCT06522217

Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches

This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Evaluation

Age range

2 week–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry -Tanta university

Tanta, Gharbia Governorate, Egypt

About this study

For this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the Outpatient Clinics of several pediatric surgeons and obstetricians to the Department of Prosthodontics -Faculty of Dentistry - Tanta University.

Inclusion criteria

  • Age range from 2-3 weeks after birth.
  • Only the Non-syndromic unilateral cleft lip and palate neonates.
  • Newborn infants without any surgical intervention.

Exclusion criteria

  • Patients with the life threatening syndromes.
  • Respiratory difficulties are not considered for presurgical treatment.
  • Uncooperative guardians.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range from 2-3 weeks after birth.
  • Only the Non-syndromic unilateral cleft lip and palate neonates.
  • Newborn infants without any surgical intervention.

Exclusion criteria

  • Patients with the life threatening syndromes.
  • Respiratory difficulties are not considered for presurgical treatment.
  • Uncooperative guardians.

Treatment and study plan

nasoalveolar molding appliance

Device

making impression then make the conventional lab procedures for group A for the production of conventional appliances

digital nasoalveolar molding appliance

Device

group B scanning the model and designing the appliances on 3shap and 3d printing the appliances

Primary outcomes

  1. intraoral measurements

    Time frame: 3 -4 months

    measuring 2 points the first is the intersegmental distance in (mm) and the second is the alveolar width in (mm)

  2. extraoral measurements

    Time frame: 3-4 months

    • Nostril height in (mm)
    • Nasal dome height in (mm)
    • Columella height in( mm)
    • Nostril basal width in (mm)
    • Nostril width in (mm)

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.