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Clinical Trials/NCT06522217
NCT06522217
Completed
Not Applicable

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

Tanta University1 site in 1 country20 target enrollmentFebruary 19, 2018
ConditionsEvaluation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Evaluation
Sponsor
Tanta University
Enrollment
20
Locations
1
Primary Endpoint
extraoral measurements
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 19, 2018
End Date
February 28, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rehab Mohamed Abdallah

lecturer of removable and maxillofacial prosthodontics

Tanta University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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)

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)

Study Sites (1)

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