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

Not Applicable

Completed

• Conditions: Evaluation
• Interventions: Device: nasoalveolar molding appliance; Device: digital nasoalveolar molding appliance

• Registration Number: NCT06522217
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2018-02-19
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-28
• Status Verified: 2024-07
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-21
• Study First Posted: 2024-07-26
• Last Update Submitted: 2024-10-05
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Group A	nasoalveolar molding appliance	10 neonates receiving conventional nasoalveolar molding appliances
Digital Group B	digital nasoalveolar molding appliance	10 neonates receiving CAD- nasoalveolar molding appliances

Primary Outcome Measures

Name	Time	Method
extraoral measurements	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	3 -4 months	measuring 2 points the first is the intersegmental distance in (mm) and the second is the alveolar width in (mm)

Trial Locations

Locations (1)

Faculty of Dentistry -Tanta university; 🇪🇬 Tanta, Gharbia, Egypt