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

October 5, 2024 updated by: Rehab Mohamed Abdallah, Tanta University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt
        • Faculty of Dentistry -Tanta university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Group A
10 neonates receiving conventional nasoalveolar molding appliances
Device: nasoalveolar molding appliance
making impression then make the conventional lab procedures for group A for the production of conventional appliances
Active Comparator: Digital Group B
10 neonates receiving CAD- nasoalveolar molding appliances
Device: digital nasoalveolar molding appliance
group B scanning the model and designing the appliances on 3shap and 3d printing the appliances

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 -4 months
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)
3-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: hoda amin rashad, phd, tanta university faculty of dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2018

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 5, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RP-12-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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