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

NCT06522217 | Completed

• 1 other identifier: RP-12-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Evaluation

Keywords

nasoalveolar molding; digital nasoalveolar molding; complete unilateral cleft lip and palate

Outcome Measures

Primary Outcomes (2)

• intraoral measurements

  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

  * 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

Study Arms (2)

Conventional Group A

ACTIVE COMPARATOR

10 neonates receiving conventional nasoalveolar molding appliances

Device: nasoalveolar molding appliance

Digital Group B

ACTIVE COMPARATOR

10 neonates receiving CAD- nasoalveolar molding appliances

Device: digital nasoalveolar molding appliance

Interventions

nasoalveolar molding appliance DEVICE

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

Conventional Group A

digital nasoalveolar molding appliance DEVICE

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

Digital Group B

Eligibility Criteria

• Age: 2 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry -Tanta university

Tanta, Gharbia Governorate, Egypt

Location

Study Officials

• hoda amin rashad, phd

  tanta university faculty of dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: starting 2 conventional then 2 CAD NAM patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of removable and maxillofacial prosthodontics

Model Details: 2 groups : Group A receiving conventional nasoalveolar molding appliance and Group B receiving CAD NAM

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 26, 2024
• Study Start: February 19, 2018
• Primary Completion: January 30, 2022
• Study Completion: February 28, 2022
• Last Updated: October 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)